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

Model Number 1219-32-148

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Date 11/13/2019

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

Reason for revision: pain - the liner had disengaged from the cup and the hip was dislocated at the time of the revision operation.(b)(6) 2019 we revised this hip to find that the liner had dislocated and broken and the ceramic head was articulated on the cup.The liner and head were explanted and a new liner (lipped marathon 28 mm) and a new 28 mm head were implanted.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the head and liner were returned for examination.The test lab and bio engineering reports conclude that although it is noted that the patient is obese (bmi = 39.6, calculated from provided patient weight and height) the mode of failure of the prosthesis is multi-factorial and consideration must be given to all other potential influences such as surgical process and anatomical considerations.It is considered unlikely that a product issue is present, and post market surveillance continue per sep 419.The products shall be retained and stored in secure storage for possible future reference.Device history lot: h21947.Device history batch: null.Device history review: no anomalies found.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.

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  added: h6 (patient code).

• Brand Name: PINN MAR +4 10D 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9426629
• MDR Text Key: 169572569
• Report Number: 1818910-2019-121421
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014034
• UDI-Public: 10603295014034
• Combination Product (y/n): N
• PMA/PMN Number: K033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

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: 1219-32-148
• Device Catalogue Number: 121932148
• Device Lot Number: H21947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/02/2020; 02/10/2020
• Supplement Dates FDA Received: 01/27/2020; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 32MM +5; DELTA CER HEAD 12/14 32MM +5
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 115