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

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Ambulation Difficulties (2544); No Information (3190)

Event Date 12/16/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11145922
• MDR Text Key: 226016979
• Report Number: 0002249697-2021-00082
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327101195
• UDI-Public: 07613327101195
• Combination Product (y/n): N
• PMA/PMN Number: K974685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention