MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122132150

Device Problem Disassembly (1168)

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

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Der states patient underwent a difficult primary total hip back in (b)(6) 2017 where a revision multihole pinnacle cup was implanted.The patient had a large cyst/defect in his acetabulum requiring large amounts of bone grafts and screws.A pinnacle altrx +4/10 degree was implanted along with summit stem and a 32+1 head.All components were very good choice for this patient.A few months later patient complained of painful hip revision surgery was required.Upon inspection intraoperatively, it seemed the liner had not fully locked into pinnacle cup.A new liner was placed along with a new head.Fixation of liner was thoroughly inspected and locked properly into cup.Doi: (b)(6) 2017; dor: (b)(6) 2018; unknown hip.

Manufacturer Narrative

(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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ALTRX +4 10D 32IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7530242
• MDR Text Key: 108781347
• Report Number: 1818910-2018-60105
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016168
• UDI-Public: 10603295016168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122132150
• Device Lot Number: H79429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/16/2018
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention