MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Malunion of Bone (4529); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Subject id: 007-03395.Study no: dots.Clinical notification received for revision of failed right hip pinning for femoral neck fracture.Date of implantation: (b)(6) 2021.Date of revision: (b)(6) 2022.(right hip).Treatment: complete removal of implants and conversion to right total hip replacement.Were depuy components removed: yes.

Manufacturer Narrative

Product complaint # (b)(4).Complaint record is approved to be converted to an npi on (b)(6) 2022.There is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device. based off the information received (b)(6) 2022, the implants removed on (b)(6) 2022 were syn devices (femoral neck system) and a tha was placed as revision.Information is being forwarded to the syn team.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14976129
• MDR Text Key: 295602767
• Report Number: 1818910-2022-12678
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White