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

Model Number	6260-9-340
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level & disassociation involving a metal head that was mated with an accolade stem was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.   device history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from 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 an nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of an 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.If further information becomes available or the product is returned, this investigation will be re-opened.Not available.
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 left hip on or about (b)(6) 2010 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update: "head disassociation".

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11462027
• Report Number: 0002249697-2021-00419
• Device Sequence Number: 4189879
• Product Code: JDI
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: 09/30/2013
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: 929MME
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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