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

Catalog Number	626-00-46F
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Periprosthetic fracture (4902)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: as per pss case: periprosthetic left acetabular fracture with acetabular loosening.He also has metallosis and likely bony necrosis making a standard hemispherical component likely to fail.Rep will try to get additional product information when the revision is performed (expected in (b)(6) 2026).Otherwise, rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
Additional information received 25-mar-26, "the patient was brought to the operating room for revision hip surgery "[on (b)(6) 2026]" from a primary hip to an fda and irb approved stryker compassionate use pss device.The patient's pelvis was reported as fractured, and it required this device along with multiple screws and a restoration modular femoral hip stem to restore stability to the joint.".
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving a mdm liner was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.-device history review: a review of the device history records could not be performed as lot code information was unknown.-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 product details, operative and revision reports, 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: 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 NA ; EI NA ; +353 61498200
• MDR Report Key: 23829951
• Report Number: 0002249697-2025-01479
• Device Sequence Number: 21071533
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 626-00-46F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 235 LB