MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT SER. II INSERT-10 DEG.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2041-2858
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Poly / head swap to address normal long term poly wear of total left hip.Surgeon scheduled procedure after patient office visit.Operative side was left hip.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event an event regarding wear involving a omnifit liner was reported.The event was not confirmed.Method & results -product 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.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Poly / head swap to address normal long term poly wear of total left hip.Surgeon scheduled procedure after patient office visit.Operative side was left hip.

• Brand Name: OMNIFIT SER. II INSERT-10 DEG.
• Common Device Name: 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13049256
• Report Number: 0002249697-2021-02074
• Device Sequence Number: 11740463
• Product Code: LPH
• UDI-Device Identifier: 04546540035400
• UDI-Public: 04546540035400
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K943054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/04/2022

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: 02/28/2007
• Device Model Number: 2041-2858
• Device Catalogue Number: 2041-2858
• Device Lot Number: 78102701
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2002
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG