MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 PINN MAR NEUT 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 121932052

Device Problem Disassembly (1168)

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Date 05/15/2018

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

Business unit: depuy (b)(4) date j&j became aware: (b)(4) 2018, date of event: (b)(6) 2018, name of reporter: (b)(6), hospital name: (b)(6), product name: pinnacle, product code:121932052, lot/batch/exp: c79076.Was the product being used in a clinical trial? no.Did the event happen during a procedure? no.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? poly liners was replaced and a new head implanted.Was there any consequence to the patient due to the event? yes failure to be mobile due to liner dislocation.Was the surgery prolonged due to the event? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? no.Please give a detailed explanation of the event: the patient was operated on (b)(6) 2017.For 6 months everything was fine but presented in jan with a clucking hip.This occurred after the patient jarred his hip while hiking.The surgeon stated the liner had dislocated and the locking mechanism for the poly did not appear damaged.Hence he replaced the poly liner and head.All appeared to seat well and reduced the hip.It was a left hip, the primary and revision were performed by mr (b)(6).Some metallosis was seen however on inspection the surgeon was happy with the locking mechanism.The implants were a pinnacle shell 52 mm, 32mm neutral liner and +5mm 32mm head.Replaced with (b)(4) lot d18020202; (b)(4) lot hn8096; (b)(4) lot 8717901.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint #:(b)(4).Investigation summary :depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: PINN MAR NEUT 32IDX52OD
• 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: 7595991
• MDR Text Key: 110991594
• Report Number: 1818910-2018-62025
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: 10603295013907
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121932052
• Device Lot Number: C79076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Date Device Manufactured: 09/12/2016
• 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