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

Model Number	6260-9-036
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional 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.
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 her left hip on or about (b)(6) 2007 and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
Reported event: an event regarding wear/metallosis 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: "the implant record from the index surgery confirms an lfit v40 head was implanted.The revision operative report dated (b)(6) 2019 states there was significant metallosis within the joint.The head had not dissociated but was grossly loose.Once the head was removed the surgeon noted significant deformation of the trunnion with material loss leaving the appearance of a "pointed tip." there is no documentation to confirm or refute elevated serum metal ion levels.The root cause of this issue cannot be established from this limited documentation.Should additional information become available i would be happy to further this assessment." -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: it was reported that the patient's hip was revised due to excessive levels of chromium and cobalt in her blood, trunnion wear, and metallosis.The subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of this 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 (b)(6), 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.No further investigation is required.No further investigation is required.
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 her left hip on or about (b)(6), 2007 and was revised on (b)(6), 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.Update 07-sep-2022 mf: per provided revision operative report: "the pre-existing femoral head component was metallic, it was noted to be grossly loose but still remaining on the trunnion of the stem.The trunnion of the existing stem was inspected and had been severely deformed down to a pointed tip.[.] there was noted to be significant metallosis." the shell and liner were also revised, but there were no reported allegations against these devices.The patient was revised to a competitor construct.

• Brand Name: V40 COCR LFIT HEAD 36MM/-5
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14197931
• Report Number: 0002249697-2022-00610
• Device Sequence Number: 14548765
• Product Code: JDI
• UDI-Device Identifier: 07613327032291
• UDI-Public: 07613327032291
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 01/31/2012
• Device Model Number: 6260-9-036
• Device Catalogue Number: 6260-9-036
• Device Lot Number: 21263902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2007
• 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: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female