MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT CROSSFIRE 10 DEG CROSSFIRE UHMWPE INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	2041C-2246
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Information (3190)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
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.Device not returned.
Event or Problem Description
First surgery (b)(6) 2004.Right hip revision surgery.Replace liner and head.Polyethylene, series ii liner 22mm inner diameter, c cup 46 48mm edge was scraped.Probably due to polyethylene wear.
Event or Problem Description
First surgery (b)(6) 2004.Right hip revision surgery.Replace liner and head.Polyethylene, series ii liner 22mm inner diameter, c cup 46 48mm edge was scraped.Probably due to polyethylene wear.
Additional Manufacturer Narrative
Reported event: an event regarding damage involving an omnifit liner was reported.The event was confirmed through material evaluation of the returned device.Method & results:  -device evaluation and results: the device was returned for evaluation.Discoloration and in vivo use is visible on the device.Damage consistent with explantation process is also visible on the device and its locking wire.Examination by engineer indicated common damage modes of uhmwpe present on the returned device.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant .-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: the device was returned for evaluation.Discoloration and in vivo use is visible on the device.Damage consistent with explantation process is also visible on the device and its locking wire.Examination by engineer indicated common damage modes of uhmwpe present on the returned device.Explantation damage was also observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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.

• Brand Name: OMNIFIT CROSSFIRE 10 DEG CROSSFIRE UHMWPE INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11145922
• Report Number: 0002249697-2021-00082
• Device Sequence Number: 608250
• Product Code: JDI
• UDI-Device Identifier: 07613327101195
• UDI-Public: 07613327101195
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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 Model Number: 2041C-2246
• Device Catalogue Number: 2041C-2246
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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