MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN BANTAM W/GRIPTION 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-30-044

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

(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 the patient had anterior hip last fall and had done well until about a month ago, but had dislocated 2 times.The patient brought to or for cup revision as it appeared via serial radiograph that the cup had moved at some point and had increased anteversion allowing anterior dislocation.Cup appeared to have approximately 30 degrees of anteversion.Surgeon removed cup and replaced with a dual mobility shell.Doi: (b)(6) 2019.Dor: (b)(6) 2020.Affected side: right 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.

• Brand Name: PINN BANTAM W/GRIPTION 44MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10112329
• MDR Text Key: 193611409
• Report Number: 1818910-2020-13051
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009948
• UDI-Public: 10603295009948
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-30-044
• Device Catalogue Number: 121730044
• Device Lot Number: J08Z57
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 28ID X 44OD; DELTA CER HEAD 12/14 28MM +5
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR