MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 PINN MAR +4 10D 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 121932148

Device Problems Disconnection (1171); Fracture (1260); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348); Not Applicable (3189)

Event Date 07/06/2018

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

Revision right total hip joint replacement for 'failed' primary components as patient presented with pain, and described a clunk plus squeaking and grating noises, of which patient claims was over 18 months in duration.Patient was seen in clinic on the (b)(6) 2018.According to surgeon, the patient had obvious radiological evidence and clinical presentation to determine revision surgery required.Uncertain of why there was a delay between when the surgeon notified to the date of surgery.Surgeon performed a routine posterior approach in order to explant the affected implants, of which was the acetabular components only.The patient has a corail stem in-situ of which was well fixed and non-affected.All implants that were explanted were collected as best possible and are available for further review.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the acetabular liner does find evidence to support the reported disassociation event.Product error/contribution to the event is not identified.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: 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 MAR +4 10D 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7742049
• MDR Text Key: 115783555
• Report Number: 1818910-2018-65613
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014034
• UDI-Public: 10603295014034
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121932148
• Device Lot Number: FD5AA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/09/2018; 12/14/2018
• Supplement Dates FDA Received: 08/15/2018; 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2011
• 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: 73 YR