MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-232
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the recurrent dislocations ending in (b)(6) 2021.It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr (b)(4) femoral head on her right hip on or about (b)(6) 2012 and was revised on (b)(6) 2021.It is further alleged that she 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 her blood.Medical records indicated that the patient had recurrent dislocations, with the final dislocation occurring in (b)(6) 2021.
Additional Manufacturer Narrative
An event regarding instability involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the revision of right total hip replacement about 9 years after implantation due to recurrent instability and trunnion corrosion.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Recurrent instability is a common postoperative complication and is multifactorial, including surgical technique and patient factors.Trunnion corrosion is also multifactorial including implant factors, surgical technique and patient factors." 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 lot referenced.Conclusion: a review of the provided medical records by a clinical consultant was unable to confirm the device failure events.The exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 32MM +4 LFIT V40 HEAD
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13257063
• Report Number: 0002249697-2022-00078
• Device Sequence Number: 11158048
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2022

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: 01/31/2017
• Device Model Number: 6260-9-232
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 38757803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female