MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_32D 10° LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: device; unknown 32mm biolox head; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.H3 other text : device not returned.

Event Description

Rep left a message that the patient's right hip was revised.As reported: "i'm doing a case where i'm removing a liner.Lesion behind cup." update 01/november/2023 wg: spoke to rep.Initial patient complaint was pain.A poly liner and ceramic head were exchanged.Rep provided imaging and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding osteolysis and wear involving an unknown liner was reported.The event 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 indicated: this inquiry concerns a 69-year-old patient who underwent a cementless total hip arthroplasty in 2014 and then approximately 10 years later required revision for what would appear to be polyethylene wear and osteolysis with a lesion behind the acetabular component.I can confirm that the patient had the primary total hip arthroplasty.It is very difficult to confirm the side based upon the x-rays since the side markers are contradictory.I cannot confirm that the revision occurred since i have no documentation such as office notes, operation note or post revision x-rays.The root cause of this event cannot be determined with certainty.Causes of failure of an acetabular cup with polyethylene wear and osteolysis are multifactorial including surgical technique factors including proper positioning in terms of inclination and anteversion, patient factors including activity level in bmi, and implant factors.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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device identification, return of the device, office notes, pre and post operative notes are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Rep left a message that the patient's right hip was revised.As reported: "i'm doing a case where i'm removing a liner.Lesion behind cup." update 01/november/2023 wg: spoke to rep.Initial patient complaint was pain.A poly liner and ceramic head were exchanged.Rep provided imaging and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN_32D 10° LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18145863
• MDR Text Key: 328224828
• Report Number: 0002249697-2023-01418
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/14/2024
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 66 KG