MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR ETO +4 10D 32IDX56OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122432156

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

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

It was reported that about 12 years ago, the patient underwent the tha surgery with the pinnacle cup, aml-stem, metal liner, and metal head. The surgery was completed successfully without any surgical delay. After the surgery, the tumor was formed due to the effect of metal liner and metal head, so they were replaced with a polyethylene liner and a new metal head. No further information is available.

• Brand Name: PINN MAR ETO +4 10D 32IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12480536
• MDR Text Key: 271663699
• Report Number: 1818910-2021-20223
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 122432156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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 Treatment Data

Date Received: 09/16/2021 Patient Sequence Number: 1

Treatment

9/10 COCR HEAD 32MM +3; PINN MAR ETO +4 10D 32IDX56OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM