MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE SZ 1 STD OFFSET; MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

Catalog Number 152101000

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on the morning of (b)(6) 2019 surgeon asked the rep to look at aa x-ray of a patient he was revising to help identify the implants he was revising.The x-ray appeared to be a duraloc cup and endurance stem.The rep was able to get duraloc liners for an insert exchange.Surgeon explanted a loosened cemented endurance stem at bone to cement, cement to implant interface and alumina hip ball and implanted a competitor stem and exchanged a 28 x 50 10 degree duraloc liner and locking ring.The cat # for the duraloc liner was not legible but the lot # was recorded.Surgeon was not sure who did the primal surgery or when and where it was done.No pre-op or post op information is available.Doi: unknown.Dor: (b)(6) 2019.Right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: d4.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ENDURANCE SZ 1 STD OFFSET
• Type of Device: MISCELLANEOUS HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9104138
• MDR Text Key: 164284128
• Report Number: 1818910-2019-105758
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 152101000
• Device Lot Number: 847640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 28MM X 50MM 10 DEGREE LINER; ALUMINA HIP BALL; DURALOC DYNAMIC LOCK RING 50MM; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 103