MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-154

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 12/22/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

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

Clinical adverse event received for right hip posterior dislocation, initial.Event is serious and is considered mild.Event is definitely related to device and is definitely not related to procedure.Date of implantation: unknown; date of revision: (b)(6) 2018; date of event (onset): (b)(6) 2019; (right hip).Treatment: closed reduction/manipulation.

Manufacturer Narrative

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.  h10 additional 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 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: ALTRX +4 10D 36IDX54OD
• 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: 9693900
• MDR Text Key: 185456818
• Report Number: 1818910-2020-04490
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016410
• UDI-Public: 10603295016410
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2020

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: 1221-36-154
• Device Catalogue Number: 122136154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 02/03/2020; 03/24/2020
• Supplement Dates FDA Received: 02/28/2020; 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 14/16 LG TAPER M HEAD 36MM+5; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 85