MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT CEMENTED LONG STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6088-0525-250R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
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 other similar events for the lot referenced.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.
Event or Problem Description
Patient presented with a femur fracture including a broken long cemented stem.We respected the proximal femur and implanted a proximal femur replacement.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture and crack/fracture involving an omnifit stem was reported.The event was confirmed via medical review.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided x-ray by a clinical consultant indicated: "material reviewed: (b)(6) 2021: stryker pi report.Undated/unlabeled: ap hip x-ray.Long cemented stem with larger head and uncemented cup (a bit flat).The femur is fractured at the proximal-mid 1/3 junction.He stem is fractured at this site as well.There was some lucency proximal around the cement mantle, age in determined.Confirmation: a femur fracture with a fractured femoral long cemented stem were confirmed.The revision surgery cannot be confirmed without additional records.¿ root cause: the root cause of the fractures cannot be determined without additional medical records." device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other similar events were reported for the lot.Conclusion: it was reported that the patient was revised due to periprosthetic fracture of the femur and fracture of the cemented long stem.This event was confirmed by the consulting clinician's review of the provided x-ray image.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative 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.
Event or Problem Description
Patient presented with a femur fracture including a broken long cemented stem.We respected the proximal femur and implanted a proximal femur replacement.

• Brand Name: OMNIFIT CEMENTED LONG STEM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 12550871
• Report Number: 0002249697-2021-01646
• Device Sequence Number: 12042720
• Product Code: JDI
• UDI-Device Identifier: 07613327022094
• UDI-Public: 07613327022094
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K913812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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 Expiration Date: 07/31/2023
• Device Model Number: 6088-0525-250R
• Device Catalogue Number: 6088-0525-250R
• Device Lot Number: AD12H9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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: 71 YR
• Patient Sex: Female