MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6260-9-340
Medical Device Problem Codes	Corroded (1131); Degraded (1153); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2007 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of chromium and cobalt in his blood.
Additional Manufacturer Narrative
Reported event an event regarding disassociation, corrosion, osteolysis and 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 the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a right total hip arthroplasty approximately 13 years after implantation due to femoral loosening, osteolysis, and head disassociation.I can confirm this event took place since i was able to read the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral loosening or multifactorial including surgical technique factors, patient activity factors and patient¿s height and weight.Causes of osteolysis are multifactorial including poly wear and other types of particle synovitis.Causes of head disassociation are multifactorial including trunnion failure, and corrosion.In this case i cannot confirm corrosion since there is no metallurgical analysis.-product history review: review of the device history records indicate the 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: lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.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
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2007 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of chromium and cobalt in his blood.*update on (b)(6) 2022 per clinician review: "[.] an operative note by dr.Dated (b)(6) 2020 is provided.The preoperative diagnosis was ¿mechanical loosening of prosthetic hip¿ and the postop diagnosis was the same.The operation performed was a revision right total hip arthroplasty.The surgeon used a cementless 70 mm shell, a polyethylene with a 28 mm inner diameter, a wagner sl femoral stem was utilized, demineralized bone putty, and a 28 mm femoral head was utilized.Femoral component was grossly loose.There was no evidence of infection.The surgeon describes a huge amount of osteolysis with "amorphous sludge type of whitish gray material".He states that the femoral head was disassociated from the femoral stem and there was a large amount of corrosive black typical material on both the male trunnion as well as the female portion of the femoral head.[.] " per operative report: "[.] the explant osteotome was used to remove the well-fixed acetabular component.There were no significant defects behind the acetabular shell.[.] ".

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12860269
• Report Number: 0002249697-2021-01948
• Device Sequence Number: 4163969
• Product Code: LPH
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2012
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: 8PEMKD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2007
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male