MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN BANTAM W/GRIPTION 46MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121730046

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Unintended Movement (3026); Migration (4003)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 11/01/2019

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 the original implant date is unknown.Doctor said patient hip was dislocated due to the cup coming dislodged from acetabulum.It was indicated that there was loosening of the cup at the bone to implant interface.He removed the acetabular components and femoral head from the trilock stem.The stem was well fixed, so he wanted to leave that.He revised the cup with a competitor multihole component.Doi: unknown.Dor: (b)(6) 2019.Right hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN BANTAM W/GRIPTION 46MM
• 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: 9383684
• MDR Text Key: 168455335
• Report Number: 1818910-2019-118392
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295009955
• UDI-Public: 10603295009955
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121730046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 28IDX46OD; DELTA CER HEAD 12/14 28MM +8.5; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 47