MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JOINT REPLACEMENT_POLY LINER; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number UNK_JR

Device Problem Naturally Worn (2988)

Patient Problem Injury (2348)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The surgeon reported that he undertook a revision of an exeter stem which had been implanted approximate ly 9 years ago.The stem had broken under the trunnion **update* * during surgery it was noted that the poly liner was damaged and abraded.

Manufacturer Narrative

Poly was reported as noted as abraded in event description.It was since discovered on review of the op note that the liner is competitor product and therefore the investigation is to be cancelled.No further reports will be submitted for this device.

Event Description

The surgeon reported that he undertook a reivsion of an exeter stem which had been implanted approximate ly 9 years ago.The stem had broken under the trunnion **update* * during surgery it was noted that the poly liner was damaged and abraded.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_POLY LINER
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8874178
• MDR Text Key: 153686359
• Report Number: 0002249697-2019-02773
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 111