MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX NEUT 28IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-28-052

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/19/2019

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.(b)(4).

Event Description

The patient was revised due to instability.All information available has been included that could be attained.No instruments were broken during surgery.Doi: unknown, dor: (b)(6) 2019, left hip.

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.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 NEUT 28IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9450676
• MDR Text Key: 173001320
• Report Number: 1818910-2019-122260
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295015963
• UDI-Public: 10603295015963
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 1221-28-052
• Device Catalogue Number: 122128052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 80