MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-321; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6276-1-321
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: as reported by hcp: i just received word that our compassionate use patient was sent to the emergency department from the ortho clinic.Patient had her 8 week follow up in clinic today with complaints of new onset right hip pain and clicking for the last 2 weeks.On x-ray, the hip was found to be dislocated.She has been admitted to the hospital and will have a revision tomorrow.We'll know more tomorrow.Per pss team: a patient specific flanged acetabular cup (p/n: c-mm100731-00) was implanted.Additional information from sales rep: the entire ((b)(6) 2026) revision was stryker projects with rest mod in the femur and mdm construct in the cup (note: the (b)(6) 2026 surgery to implant stryker implants was a revision of non-stryker implants).The reason for the dislocation was a brace was removed from the patient during pt (brace was removed by physical therapist against surgeon advice after having been asked 3 times to remove the brace) and her entire greater trochanter broke off due over movement of the operative leg.It was discovered yesterday, in surgery, that her abductors were no longer attached to keep the hip in place.The mdm construct was replaced with a stryker constrained liner to keep her hip from further dislocation.Rep provided x-rays and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: restoration adm x3 ins 28/48; cat # 7236-2-848; lot # l62rd6, modular dual mobility insert; cat # 626-00-42e; lot # 33424053.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: 21MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-321
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25017086
• Report Number: 0002249697-2026-00340
• Device Sequence Number: 9655357
• Product Code: JDI
• UDI-Device Identifier: 07613154057917
• UDI-Public: 07613154057917
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 6276-1-321
• Device Lot Number: 85286301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 63 KG