MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-236

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 07/15/2022

Event Type  Injury  

Event Description

It was reported that the patient's left hip was revised.Patient fell and head dissociation was diagnosed (unknown which one caused the other).Intra-operatively, trunnion wear was noted.The stem, head, and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep confirmed he will provide all pictures and documents available to him from the hospital and surgeon.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.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 Description

It was reported that the patient's left hip was revised.Patient fell and head dissociation was diagnosed (unknown which one caused the other).Intra-operatively, trunnion wear was noted.The stem, head, and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep confirmed he will provide all pictures and documents available to him from the hospital and surgeon.Spoke with patient's wife who called patient hotline who was provided the product inquiry by the surgeon.Patient was playing golf and fell on right "buttocks" and two weeks later started feeling "something", went to surgeon and was immediately scheduled for surgery.She indicated revision required removal of "metal fragments".She indicated surgeon stated parts are part of a recall.Patient wants to know if confirm if parts subject to a recall.Patient is seeking compensation.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a lfit v40 cocr head that was mated with a citation stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.-clinician review: no medical records were provided for review with clinical consultant.-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.Conclusion: the subject device has been identified to be within scope of nc pr and capa pr.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc pr and capa pr.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 (b)(6) 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

It was reported that the patient's left hip was revised.Patient fell and head dissociation was diagnosed (unknown which one caused the other).Intra-operatively, trunnion wear was noted.The stem, head, and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep confirmed he will provide all pictures and documents available to him from the hospital and surgeon.Spoke with patient's wife who called patient hotline who was provided the product inquiry by the surgeon.Patient was playing golf and fell on right "buttocks" and two weeks later started feeling "something", went to surgeon and was immediately scheduled for surgery.She indicated revision required removal of "metal fragments".She indicated surgeon stated parts are part of a recall.Patient wants to know if confirm if parts subject to a recall.Patient is seeking compensation.Update (b)(6) 2023: this pi is for the right hip.Patient was revised to remove "metal fragments" and recall inquiry.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a lfit v40 cocr head that was mated with a citation stem was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.Clinician review: no medical records were provided for review with clinical consultant.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.Conclusion: the subject device has been identified to be within scope of nc pr and capa pr.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc pr and capa pr.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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15154611
• MDR Text Key: 297141947
• Report Number: 0002249697-2022-01140
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MHAN38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 02/17/2023
• Supplement Dates FDA Received: 11/04/2022; 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 125 KG