MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	626-00-42E
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: (b)(6) 2017, right first tha twice anterior dislocations in february 2022 (b)(6) 2022, revision surgery was performed.A sliding surface was replaced.The stem continued to be used.(b)(6) 2025, bleeding from the wound due to suspected infection no fever, but a feeling of heat in the affected area and a soft mass due to suspected infection, the implant was removed and a cement mold placed.There was a notch in the neck of the stem, and it appeared to be hitting the mdm liner.The cup front opening was 44° and the stem front twist was 36°.The wound was covered with black tissue, so it was debrided and cleaned.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding altr involving an mdm liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the returned device indicated damaged from contact with explantation tooling and the time spent implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that '(b)(6) 2025, bleeding from the wound due to suspected infection no fever, but a feeling of heat in the affected area and a soft mass due to suspected infection, the implant was removed and a cement mold placed.There was a notch in the neck of the stem, and it appeared to be hitting the mdm liner.The cup front opening was 44° and the stem front twist was 36°.The wound was covered with black tissue, so it was debrided and cleaned.' visual inspection of the returned device indicated damaged from contact with explantation tooling and the time spent implanted.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays 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: MODULAR DUAL MOBILITY INSERT
• Common Device Name: 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 23106952
• Report Number: 0002249697-2025-01007
• Device Sequence Number: 10143433
• Product Code: LZO
• UDI-Device Identifier: 04546540666017
• UDI-Public: 04546540666017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Catalogue Number: 626-00-42E
• Device Lot Number: 96174801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown