MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 0580-1-374

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Not available.

Event Description

During the primary total hip arthroplasty, the following product was found to be defective: 0580-1-374 lot g7676165.The distal end of the pin is thicker than it should be.Unable to put on the centralizer.

Event Description

During the primary total hip arthroplasty, the following product was found to be defective: 0580-1-374 lot g7676165.The distal end of the pin is thicker than it should be.Unable to put on the centralizer.

Manufacturer Narrative

Reported event: an event regarding size/fit issue involving a exeter stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: inspection was carried out and noted the following: no damage is visible on the stem.The global shape of the stems, especially the end of the stem, has been inspected without any discrepancy.Dimensional inspection of the returned device noted the following: during manufacturing process, the end of the stem is 100% inspected by gauge width and thickness locations at the polishing step and then 10% inspected during final inspection as requested on the igs.Dimensional inspection was performed on the part sent back as defined in manufacturing instruction.This dimensional inspection has been performed with a go/no go gauge.This gauge is maintained on a tool to guarantee the location of the stem during the inspection.The tool and the gauge are registered in lmo and reviewed on defined frequencies each year.The end of the stem is compliant in both the width and thickness position.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: the inspection found that the stem is compliant.A review of the exeter stem surgical protocol, noted the following: the stem centralizer is not retentive and when placed on the tip of the stem it may need to be held in place as the stem is transferred to the femur ready for insertion.The centralizer should not be forced excessively onto the stem tip.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.

• Brand Name: EXETER V40 STEM 37.5MM NO 4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11192935
• MDR Text Key: 227799682
• Report Number: 0002249697-2021-00146
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540153289
• UDI-Public: 04546540153289
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0580-1-374
• Device Catalogue Number: 0580-1-374
• Device Lot Number: G7676165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other