MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121730056

Device Problems Disconnection (1171); Off-Label Use (1494); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)

Event Date 07/27/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges pain, discomfort, limited mobility, grinding sensations, audible squeaking and toxic cobalt and chromium metal debris to be released into the tissue.Records indicate that the patient was revised because the liner was loose from the shell.Records are available for further review.Ppf alleges loosening of cup.Pfs alleges that the surgical leg was an inch longer than the healthy side causing intense pain in the lower back.After review of medical records for the mdr reportability, patient was revised to address failed tha.Intraop findings reported of ho along the outer aspect of the cement block and a little on the medial side of the cup.The cement was removed without difficulty.The inner cup was loose.There was a fibrous interface but the cup was mobile and had created a thin black membrane of metal debris from the screw heads moving against the cup.There was significant instability with a 4-6 mm shuck when restoring the hip's normal position.Doi: (b)(6) 2010 - dor: (b)(6) 2011(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MULTIHOLE W/GRIPTION 56MM
• 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 US; 700 orthopaedic drive; warsaw IN 46581
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7841667
• MDR Text Key: 119036787
• Report Number: 1818910-2018-68311
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010005
• UDI-Public: 10603295010005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 121730056
• Device Lot Number: D5GF31000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 79