MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 0580-1-440

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has not yet been revised.No other information is available at this time.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

The customer reported that a patient who had been implanted with an exeter mitch combination needs revision.

Manufacturer Narrative

An event regarding revision for unspecified reason involving an exeter stem was reported.The event was not confirmed.Method & results: product evaluation and results: the stem was returned for evaluation.The damage on the stem is consistent with implantation and explantation processes.Nothing else remarkable was noticed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's hip was revised for unspecified reason.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Catalog numbers and lot codes of oem devices listed in this report: cat# mac-9988-4854; std mitch trh cp sz 48/54; lot# fm59166018.Cat# mmh-9988-0048; mitch trh md hd sz 48+0; lot# fm80523.

Event Description

The customer reported that a patient who had been implanted with an exeter mitch combination needs revision.

• Brand Name: EXETER V40 STEM 44MM NO 0
• 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: 11119166
• MDR Text Key: 225279439
• Report Number: 0002249697-2021-00036
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G1567951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 56 YR