MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT SER. II INSERT 20 DEG.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2042-2858
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.
Event or Problem Description
As reported: "right hip.Acetabular poly and femoral head exchange.Normal poly wear.".
Additional Manufacturer Narrative
An event regarding wear involving omnifit ser.Ii insert 20 deg.Was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: review of these records confirm revision of an acetabular liner and femoral head for wear and recurrent subluxation.The cause of the recurrent subluxation was polyethylene wear and impingent of the neck of the femoral stem on the acetabular liner 20 degree buidup.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that patient's right hip, acetabular poly and femoral head exchange.Normal poly wear.The event was confirmed based on medical review.A review of the provided medical records by a clinical consultant stated the following comment: review of these records confirm revision of an acetabular liner and femoral head for wear and recurrent subluxation.The cause of the recurrent subluxation was polyethylene wear and impingent of the neck of the femoral stem on the acetabular liner 20 degree buidup.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "right hip.Acetabular poly and femoral head exchange.Normal poly wear." update as per medical review,"confirm revision of an acetabular liner and femoral head for wear and recurrent subluxation.".

• Brand Name: OMNIFIT SER. II INSERT 20 DEG.
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9855601
• Report Number: 0002249697-2020-00551
• Device Sequence Number: 16797186
• Product Code: LPH
• UDI-Device Identifier: 04546540036155
• UDI-Public: 04546540036155
• 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 Implanted Year: 2001
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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 Model Number: 2042-2858
• Device Catalogue Number: 2042-2858
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 102