MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-054

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Date 04/01/2022

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

Patient revised due to pain for post operation fall and pelvis fracture.Cup was revised and patient reported multiple falls.Implants not fractured.Cup had to be cut out of acetabulum.Doi: (b)(6) 2019.Dor: (b)(6) 2022.Affected side: left hip.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN SECTOR W/GRIPTION 54MM
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14141409
• MDR Text Key: 289499559
• Report Number: 1818910-2022-06974
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010319
• UDI-Public: 10603295010319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1217-32-054
• Device Catalogue Number: 121732054
• Device Lot Number: 8911668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• 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
• Treatment: ALTRX NEUT 36IDX54OD; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 54MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female