MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-040
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional 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.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.
Event or Problem Description
It was reported that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2011 and was revised on (b)(6) 2018.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and abnormal ion level involving an involving a lfit v40 cocr head was reported.The event of corrosion was confirmed through evaluation of the provided medical records.The event of abnormal ion level 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 by a clinical consultant stated the following comment: "on (b)(6) 11the patient underwent an uncomplicated tha.In 2018 the patient was evaluated and found to have a painful tha.A workup was initiated and per the revision surgeon's operative note she had significantly elevated serum metal ion levels.Intra-operatively a large cloudy effusion was encountered.Upon removal of the v-40 femoral head the surgeon remarked the there was a great deal of corrosion on the trunnion but he was able to "scrub it off" and leave the stem in place.The surgeon felt the cup was in a suboptimal vertical position.The cup was revised and a new liner placed.A sleeve and new head were implanted.As well.It is confirmed that a revision tha surgery for pain and elevated serum metal ions and trunnionois occurred.No direct evidence for elevated serum metal ions was presented but the surgeon noted they were elevated in his operative report the root cause of the tha trunnionosis cannot be determined from the documentation provided.Should additional information become available i would be happy to further this assessment." -device 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 reported lot.Conclusions 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 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 (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 or Problem Description
It was reported that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2011 and was revised on (b)(6) 2018.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, and excessive levels of chromium and cobalt in her blood.Update as per medical review: ".The surgeon felt the cup was in a suboptimal vertical position.The cup was revised and a new liner placed.A sleeve and new head were implanted.As well.".

• Brand Name: V40 COCR LFIT HEAD 40MM/-4
• 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, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 8833382
• Report Number: 0002249697-2019-02692
• Device Sequence Number: 2119202
• Product Code: JDI
• UDI-Device Identifier: 07613327032703
• UDI-Public: 07613327032703
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 08/31/2015
• Device Catalogue Number: 6260-9-040
• Device Lot Number: MJMNTD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male