MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-444
Medical Device Problem Codes	Misassembled (1398); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
During hip arthroplasty surgery, an exeter 44-4 stem was found to be defective (ref 0580-1-444, lot g7681256).The distal end of the stem was thicker than it should be.The centralizer does not fit on the leg.
Event or Problem Description
During hip arthroplasty surgery, an exeter 44-4 stem was found to be defective (ref (b)(6), lot g7681256).The distal end of the stem was thicker than it should be.The centralizer does not fit on the leg.
Additional 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 centraliser 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 centraliser 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 44MM NO 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11054304
• Report Number: 0002249697-2020-02742
• Device Sequence Number: 14124254
• Product Code: JDI
• UDI-Device Identifier: 04546540153333
• UDI-Public: 04546540153333
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 0580-1-444
• Device Catalogue Number: 0580-1-444
• Device Lot Number: G7681256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other