MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 42MM METAL-ON-METAL METAL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 01/04/2023

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a rtha with abgii modular in june of 2011 experienced osteolysis, necrosis, adverse local tissue reaction and pain.Plaintiff underwent girdlestone surgery on (b)(6) 2021.During the procedure it was noted ¿posterior wall was quite deficient, the superior dome was intact but there was a medical wall defect.The modular neck was removed and found to be coated with black material.Severe bone destruction was noted around the acetabular at this time.¿ ¿in december of 2021, the plaintiff underwent a surgery to attempt to implant an artificial pelvic model.However, this procedure was unsuccessful and the plaintiff has been left wheelchair bound.

Manufacturer Narrative

Reported event: an event regarding altr involving a unknown liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual, dimensional, functional and material analysis not be performed as the device is not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records could not be performed as lot information was not provided.Complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: it was reported that patient hip was revised due to altr.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.Device not returned to the manufacturer.

• Brand Name: UNKNOWN 42MM METAL-ON-METAL METAL LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16261346
• MDR Text Key: 308347115
• Report Number: 0002249697-2023-00081
• Device Sequence Number: 1
• Product Code: LZO
• 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: 01/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/28/2023
• 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 Sex: Female