MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Break (1069)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 04/25/2019

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

It was reported that the patient's right hip was revised due to the trunnion of the stem breaking off, disconnecting the stem from the head.Intra-operatively, a little black tissue was noted in the patient along with damage to the poly liner.Patient was revised to a restoration modular stem construct with a ceramic head.Rep provided a primary operative report, pre-revision x-rays, and explant pictures and reported that no further information will be available.

Manufacturer Narrative

An event regarding damage involving an unknown liner was reported.The event of was confirmed by provided photographs.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted poly liner with delaminated edge.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "x-rays confirms trunnion disassociation; need revision operative report, clinical and past medical history and examination of explanted components." -product 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.  conclusions the liner was implanted with an accolade stem and a lfit v40 cocr head which has been identified to be within scope of nc and capa.The exact cause of the event could not be determined because insufficient information was provided.  additional information including device details, operative reports, progress notes, x- rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the patient's right hip was revised due to the trunnion of the stem breaking off, disconnecting the stem from the head.Intra-operatively, a little black tissue was noted in the patient along with damage to the poly liner.Patient was revised to a restoration modular stem construct with a ceramic head.Rep provided a primary operative report, pre- revision x-rays, and explant pictures and reported that no further information will be available.

• Brand Name: UNKNOWN POLY LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8628881
• MDR Text Key: 145671334
• Report Number: 0002249697-2019-02031
• Device Sequence Number: 1
• Product Code: LZO
• 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: 07/02/2019

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR