MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-050

Device Problem Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Joint Disorder (2373); No Code Available (3191)

Event Date 10/16/2017

Event Type  Injury  

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.Initial reporter occupation: lawyer.(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

Ppf and medical records received.There are no allegations from the ppf.After review of medical records, the patient was revised due to an unknown reason.Doi: (b)(6) 2010 (cup and 1 screw).Doi: (b)(6) 2016 (liner, head and proximal body).Doi: (b)(6) 2017 (1 screw).Dor: (b)(6) 2017 (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.Patient code: removed code for medical device removal and surgical intervention and replaced with device revision or replacement.

• Brand Name: PINN SECTOR W/GRIPTION 50MM
• 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: 9409998
• MDR Text Key: 169050863
• Report Number: 1818910-2019-120130
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010296
• UDI-Public: 10603295010296
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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: 1217-32-050
• Device Catalogue Number: 121732050
• Device Lot Number: EA5DW1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR