MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-056

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 05/08/2020

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

The patient was revised due to dislocated posterior. Doi: unknown. Dor: (b)(6) 2020. Left hip.

• Brand Name: PINN SECTOR W/GRIPTION 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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 drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10093160
• MDR Text Key: 192247571
• Report Number: 1818910-2020-12654
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/27/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 1217-32-056
• Device Catalogue Number: 121732056
• Device LOT Number: 9393855
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/05/2020
• 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: 05/27/2020 Patient Sequence Number: 1

Treatment

ALTRX +4 NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM +8.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 56MM