MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Pain (1994); Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle medical records received.After review of the medical records the patient was revised to address, pain, instability and lengthening of the hip to ceramic head ball and polyethylene liner exchanged.Doi: (b)(6) 2014, dor: (b)(6) 2015, right hip 1st revision.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12359293
• MDR Text Key: 267859600
• Report Number: 1818910-2021-18489
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 40IDX60OD.; CORAIL AMT COLLAR SIZE 13.; PINN CAN BONE SCREW 6.5MMX40MM.; PINN SECTOR W/GRIPTION 60MM.; UNK HIP FEMORAL HEAD.; UNKNOWN HIP ACETABULAR LINERS.; UNK HIP FEMORAL HEAD; UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR