MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS 1818910 AMK TIB INS SIZE 2 10MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 148841025

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); No Information (3190); No Code Available (3191)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Patient was revised to address wear.The wear was noted through routine x-ray follow-up.

Manufacturer Narrative

No device associated with this report was received for examination.Review of provided patient x-rays finds narrowing of the joint space on the medical aspect suggesting device wear.The device was implanted for approximately nineteen years before revision.A worldwide complaint database search found no other reported incidents against the provided product/lot combination since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd 10/11/2016 - the patient's medical records were received.After review of the medical records for mdr reportability, the revision operative note also indicated pain, discomfort, swelling, catching, stiffness, laxity, and clicking.The insert was noted to have no delamination-just wear.There is no new information that would change the existing mdr decision.

• Brand Name: AMK TIB INS SIZE 2 10MM
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6004205
• MDR Text Key: 56599871
• Report Number: 1818910-2016-28891
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

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: 148841025
• Device Lot Number: RN7G21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/1997
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82