MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT ANATOMIC V40 FEMORAL HEAD 36 +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

Device Problem Degraded (1153)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 05/16/2022

Event Type  Injury  

Event Description

It was reported by claimant's counsel that allegedly the patient underwent left total hip arthroplasty on (b)(6) 2013, and was implanted with an lfit anatomic v40 femoral head and accolade ii stem.Subsequently she allegedly developed increasing left hip pain, elevated metal ion levels, and pseudotumor that required revision surgery on (b)(6) 2022.

Manufacturer Narrative

An event regarding altr involving an unknown metal head was reported.Method & results:  device evaluation and results: not performed as product was not returned.  clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that the patient was revised due to altr.The exact cause of the event could not be determined because insufficient information was provided.  additional information including device details, operative reports, progress notes, 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: UNKNOWN LFIT ANATOMIC V40 FEMORAL HEAD 36 +0
• Type of Device: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18910385
• MDR Text Key: 337730035
• Report Number: 0002249697-2024-00396
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female