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

Model Number 1217-32-050

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

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

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

Pfs and medical records received.After review of the medical records the patient was revised on (b)(6) 2016.The pfs indicated the patient was revised for dislocation and a fractured stem.The stem has already been reported on (b)(4).Part/lot hasn't been provided at this time.Ppf has no new allegations reported.After review of medical records, the patient was revised to perform an excisional irrigation and debridement as well as an extended trochanteric osteotomy of the hip to address dislocation, extensive metallosis and damaged trunnion of the femoral component.Updated the implant date of the head and the details of the impacted products doi: (b)(6) 2015 (head); doi: (b)(6) 2016 (liner); dor: (b)(6) 2016 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> investigative update: 29 / oct / 2021 x-ray images have been provided for review no device associated with this report was received for examination.X-ray images have been provided for review.The acetabular cup appears to have both more abduction and less version angle than would be recommended by depuy.Cup position is determined by the implanting surgeon and is not considered a product problem.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 material, manufacturing, inspection or sterile processing 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 50MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• MDR Report Key: 9409779
• MDR Text Key: 185192655
• Report Number: 1818910-2019-120096
• 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: 10/14/2016

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: 11/07/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 70