MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT SER. II CUP INS. 0 DEG.; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2043-2850
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following device was also listed in this report: device name: c-taper cocr lfit head 28mm/0; cat#: 06-2800; lot#: unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.Device not returned.
Event or Problem Description
As reported: "poly/ head swap.Total left hip.".
Additional Manufacturer Narrative
Reported event: an event regarding wear involving an omnifit liner was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-clinician review: a review of the provided medical records by a clinical consultant indicated, the exam of the left side showed pain with straight leg raise, pain with start-up, and with motion.The range of motion had decreased.The revision surgery was performed on (b)(6) 2020.There was abundant granulation material felt to be typical for wear debris.Minimal corrosion was noted at the trunnion.The implants were felt to be stable.There was wear of the polyethylene and resultant osteolysis in a 20 year old tha.The findings were not found to be abnormal and were consistent with expected wear patterns.Examination of the preoperative x-rays and the explanted implants would provide additional information to support the findings.-device history review: not performed as no lot code information for the reported device was provided.-complaint history review: not performed as no lot code information for the reported device was provided.Conclusions: it was reported that the patient was revised due to worn liner where head and liner were revised.A review of the provided medical records by a clinical consultant indicated, there was wear of the polyethylene and resultant osteolysis in a 20 year old tha.The findings were not found to be abnormal and were consistent with expected wear patterns.Examination of the preoperative x-rays and the explanted implants would provide additional.Information to support the findings.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: "poly/ head swap.Total left hip.".

• Brand Name: OMNIFIT SER. II CUP INS. 0 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: 10566331
• Report Number: 0002249697-2020-01958
• Device Sequence Number: 2671253
• Product Code: LPH
• UDI-Device Identifier: 04546540036834
• UDI-Public: 04546540036834
• 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: 2000
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 2043-2850
• Device Catalogue Number: 2043-2850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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: 76 YR
• Patient Weight: 91