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

Catalog Number 6260-9-236

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.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.

Event Description

It was reported the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2006 and was revised on (b)(6) 2016.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, and excessive levels of chromium and cobalt in his blood.

Event 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) 2006 and was revised on (b)(6) 2016.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Update (b)(6) 2020: the revision operative report notes that the patient was admitted with a dislocation where his trunnion disassociated from his femoral head.Intraoperatively when the proximal portion of the femur was exposed, it showed a penciled trunnion.

Manufacturer Narrative

An event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "cannot confirm event, need additional information; primary operative reports, clinical and past medical history, serial dated x-rays and examination of explanted components." device history review: all 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 reported lot.Conclusion: the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc and 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 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
• MDR Report Key: 8518004
• MDR Text Key: 142050308
• Report Number: 0002249697-2019-01611
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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: 04/30/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: WH2MHA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR