MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-244
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Pt.Called and reported that they have a recalled hip and have to have it replaced.It's osteonics accolade system and it was done (b)(6) 2013.Insurance called and said that hip was recalled.I've really suffered.The pain is really bad and can hardly walk.Pending revision.
Event or Problem Description
Pt.Called and reported that they have a recalled hip and have to have it replaced.It's osteonics accolade system and it was done (b)(6) 2013.Insurance called and said that hip was recalled.I've really suffered.The pain is really really bad and can hardly walk.Pending revision.
Additional Manufacturer Narrative
Product code d2b common device name d2a corrected as per catalog number received.An event regarding pain involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant "conclusion/assessment: the patient had a left total hip arthroplasty performed (b)(6) 2013.No records of the patient's preoperative care or conservative management were presented.She has multiple comorbid conditions including schizophrenia narcotic use back pain with some radicular pain in a number of complicated medications.She has had prior total knee arthroplasties.She did apparently have a hip joint injection that relieved her pain for a very short time.She has noted to have arthritis on the opposite side as well.The total hip appears to been performed without complication multiple records from her hospital stay, most of which were noncontributory, do not show any complications while hospitalized.No radiographs pre or postoperatively, and no pre or postoperative medical records were provided for review.There is no documented complaints of the patient relative to the hip outside of the pi report.Event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed from implant stickers.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0 degree polyethylene, accolade tmz f+ 127 degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.The patient complaints and the pi report cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as the complaints cannot be confirmed.A root cause for a recall cannot be ascertained as this cannot be confirmed.Of note the implants are labeled as osteonics rather than stryker by the patient." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.Although the reported lot code is in the scope of the capa, the reported failure mode is not in the scope of this recall.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.
Event or Problem Description
Pt.Called and reported that they have a recalled hip and have to have it replaced.It's osteonics accolade system and it was done (b)(6) 2013.Insurance called and said that hip was recalled.I've really suffered.The pain is really bad and can hardly walk.Pending revision.Update: pt.Was revised on (b)(6) 2024.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant "conclusion/assessment: the patient had a left total hip arthroplasty performed (b)(6) 2013.No records of the patient's preoperative care or conservative management were presented.She has multiple comorbid conditions including schizophrenia narcotic use back pain with some radicular pain in a number of complicated medications.She has had prior total knee arthroplasties.She did apparently have a hip joint injection that relieved her pain for a very short time.She has noted to have arthritis on the opposite side as well.The total hip appears to been performed without complication multiple records from her hospital stay, most of which were noncontributory, do not show any complications while hospitalized.No radiographs pre or postoperatively and no pre or postoperative medical records were provided for review.There is no documented complaints of the patient relative to the hip outside of the pi report.Event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed from implant stickers.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0 degree polyethylene, accolade tmz f+ 127 degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.The patient complaints and the pi report cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as the complaints cannot be confirmed.A root cause for a recall cannot be ascertained as this cannot be confirmed.Of note the implants are labeled as osteonics rather than stryker by the patient." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Pt.Called and reported that they have a recalled hip and have to have it replaced.It's osteonics accolade system and it was done (b)(6) 2013.Insurance called and said that hip was recalled.I've really suffered.The pain is really bad and can hardly walk.Pending revision.Update: pt.Was revised on (b)(6)2024.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant "conclusion/assessment: the patient had a left total hip arthroplasty performed (b)(6)2013.No records of the patient's preoperative care or conservative management were presented.She has multiple comorbid conditions including schizophrenia narcotic use back pain with some radicular pain in a number of complicated medications.She has had prior total knee arthroplasties.She did apparently have a hip joint injection that relieved her pain for a very short time.She has noted to have arthritis on the opposite side as well.The total hip appears to been performed without complication multiple records from her hospital stay, most of which were non-contributory, do not show any complications while hospitalized.No radiographs pre or postoperatively and no pre or postoperative medical records were provided for review.There is no documented complaints of the patient relative to the hip outside of the pi report.The med review addendum indicated [.] trunnion was found to "look fine" but there were black markings but no significant corrosion or structural damage.Frozen sections were "mostly normal showing a small number of neutrophils and some brown soft tissue fragments of indeterminate significance.Her follow-up on (b)(6)2024 showed well aligned implants hip that looked fine and hip was warm and dry.She was recommended to continue for therapy for 6 weeks.There are no radiographs provided for review.The final pathologic report was not provided for review.In short, the patient who had multiple other medical and social issues, most significantly for significant low back pain and stenosis, underwent revision hip surgery for increased metal levels and increased fluid collection around the hip on mri and based on presence of a large cobalt chrome lfit head which was on a tmzf stem.By report there had been a recall of the implant which was not otherwise documented.Event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0-degree polyethylene, accolade tmzf+ 127-degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.Increased metal levels can be confirmed.Revision surgery can be confirmed.Trunnionosis/corrosion cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as there were a number of comorbid conditions.A root cause for a recall cannot be ascertained as this was not confirmed.The root cause of the revision was patient pain, increased metal levels, assertion of a recall, and suspected trunnionosis.[.].Of note the implants are labeled as osteonics rather than stryker by the patient." event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed from implant stickers.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0 degree polyethylene, accolade tmz f+ 127 degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.The patient complaints and the pi report cannot be confirmed.-product history review: review of the device history records indicate 5 devices were manufactured and accepted into final stock on 11/10/2010 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the med review addendum indicated [.] trunnion was found to "look fine" but there were black markings but no significant corrosion or structural damage.Frozen sections were "mostly normal showing a small number of neutrophils and some brown soft tissue fragments of indeterminate significance.Her follow-up on (b)(6)2024 showed well aligned implants hip that looked fine and hip was warm and dry.She was recommended to continue for therapy for 6 weeks.There are no radiographs provided for review.The final pathologic report was not provided for review.In short, the patient who had multiple other medical and social issues, most significantly for significant low back pain and stenosis, underwent revision hip surgery for increased metal levels and increased fluid collection around the hip on mri and based on presence of a large cobalt chrome lfit head which was on a tmzf stem.By report there had been a recall of the implant which was not otherwise documented.Event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0-degree polyethylene, accolade tmzf+ 127-degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.Increased metal levels can be confirmed.Revision surgery can be confirmed.Trunnionosis/corrosion cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as there were a number of comorbid conditions.A root cause for a recall cannot be ascertained as this was not confirmed.The root cause of the revision was patient pain, increased metal levels, assertion of a recall, and suspected trunnionosis.[.] no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Pt.Called and reported that they have a recalled hip and have to have it replaced.It's osteonics accolade system and it was done (b)(6) 2013.Insurance called and said that hip was recalled.I've really suffered.The pain is really really bad and can hardly walk.Pending revision.Update: pt.Was revised on (b)(6) 2024.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant "conclusion/assessment: the patient had a left total hip arthroplasty performed (b)(6) 2013.No records of the patient's preoperative care or conservative management were presented.She has multiple comorbid conditions including schizophrenia narcotic use back pain with some radicular pain in a number of complicated medications.She has had prior total knee arthroplasties.She did apparently have a hip joint injection that relieved her pain for a very short time.She has noted to have arthritis on the opposite side as well.The total hip appears to been performed without complication multiple records from her hospital stay, most of which were noncontributory, do not show any complications while hospitalized.No radiographs pre or postoperatively, and no pre or postoperative medical records were provided for review.There is no documented complaints of the patient relative to the hip outside of the pi report.The med review addendum indicated [.] trunnion was found to "look fine" but there were black markings but no significant corrosion or structural damage.Frozen sections were "mostly normal showing a small number of neutrophils and some brown soft tissue fragments of indeterminate significance.Her follow-up on (b)(6) 2024 showed well aligned implants hip that looked fine and hip was warm and dry.She was recommended to continue for therapy for 6 weeks.There are no radiographs provided for review.The final pathologic report was not provided for review.In short, the patient who had multiple other medical and social issues, most significantly for significant low back pain and stenosis, underwent revision hip surgery for increased metal levels and increased fluid collection around the hip on mri and based on presence of a large cobalt chrome lfit head which was on a tmzf stem.By report there had been a recall of the implant which was not otherwise documented.Event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0-degree polyethylene, accolade tmzf+ 127-degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.Increased metal levels can be confirmed.Revision surgery can be confirmed.Trunnionosis/corrosion cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as there were a number of comorbid conditions.A root cause for a recall cannot be ascertained as this was not confirmed.The root cause of the revision was patient pain, increased metal levels, assertion of a recall, and suspected trunnionosis.[.] event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed from implant stickers.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0 degree polyethylene, accolade tmz f+ 127 degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.The patient complaints and the pi report cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as the complaints cannot be confirmed.A root cause for a recall cannot be ascertained as this cannot be confirmed.Of note the implants are labeled as osteonics rather than stryker by the patient." updated addendum indicated [.] event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0-degree polyethylene, accolade tmzf+ 127-degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.Increased metal levels can be confirmed.Revision surgery can be confirmed.Trunnionosis/corrosion cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as there were a number of comorbid conditions.A root cause for a recall cannot be ascertained as this was not confirmed.The root cause of the revision was patient pain, increased metal levels, assertion of a recall, and suspected trunnionosis.[.] product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the med review addendum indicated [.] trunnion was found to "look fine" but there were black markings but no significant corrosion or structural damage.Frozen sections were "mostly normal showing a small number of neutrophils and some brown soft tissue fragments of indeterminate significance.Her follow-up on (b)(6) 2024 showed well aligned implants hip that looked fine and hip was warm and dry.She was recommended to continue for therapy for 6 weeks.There are no radiographs provided for review.The final pathologic report was not provided for review.In short, the patient who had multiple other medical and social issues, most significantly for significant low back pain and stenosis, underwent revision hip surgery for increased metal levels and increased fluid collection around the hip on mri and based on presence of a large cobalt chrome lfit head which was on a tmzf stem.By report there had been a recall of the implant which was not otherwise documented.Event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0-degree polyethylene, accolade tmzf+ 127-degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.Increased metal levels can be confirmed.Revision surgery can be confirmed.Trunnionosis/corrosion cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as there were a number of comorbid conditions.A root cause for a recall cannot be ascertained as this was not confirmed.The root cause of the revision was patient pain, increased metal levels, assertion of a recall, and suspected trunnionosis.[.] updated addendum indicated [.] event confirmation: a left total hip arthroplasty with a stryker implant can be confirmed.The implants: trident psl ha cluster shell 56¿f, 44 mm x3 0-degree polyethylene, accolade tmzf+ 127-degree v40 #4.5, lfit anatomic v40 femoral head 44 mm +4 mm can be confirmed.Recall of the implants cannot be confirmed.Increased metal levels can be confirmed.Revision surgery can be confirmed.Trunnionosis/corrosion cannot be confirmed.Root cause: the root cause for the total hip arthroplasty was hip arthritis.The root cause for the patient complaints cannot be ascertained as there were a number of comorbid conditions.A root cause for a recall cannot be ascertained as this was not confirmed.The root cause of the revision was patient pain, increased metal levels, assertion of a recall, and suspected trunnionosis.[.].No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40 COCR LFIT HEAD 44MM/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20199652
• Report Number: 0002249697-2024-01259
• Device Sequence Number: 6857717
• Product Code: JDI
• UDI-Device Identifier: 07613327032758
• UDI-Public: 07613327032758
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 6260-9-244
• Device Lot Number: MJPJNN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 11/09/2024; 02/08/2025; 03/25/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/04/2024; 03/05/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White