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

Model Number 1221-32-050

Device Problems Disassembly (1168); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Injury (2348); Not Applicable (3189)

Event Date 05/08/2018

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 that the patient had a liner that spun out and the tabs were broken off the poly.Surgeon replaced the liner and head.Doi: (b)(6) 2015; dor: (b)(6) 2018; left hip.

Manufacturer 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, 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 will be filed as appropriate.

Manufacturer Narrative

(b)(4).

Event Description

After review of the received medical records, it was stated that patient had metallosis and fracture in the liner.

Manufacturer 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, 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.Device history lot: 569002.Device history review: a review of the dhr found no related deviations or anomalies.

• Brand Name: ALTRX NEUT 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
• MDR Report Key: 7565093
• MDR Text Key: 109912278
• Report Number: 1818910-2018-61223
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016106
• UDI-Public: 10603295016106
• Combination Product (y/n): N
• PMA/PMN Number: K102423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 1221-32-050
• Device Catalogue Number: 122132050
• Device Lot Number: 569002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 02/11/2019; 07/29/2020
• Supplement Dates FDA Received: 08/28/2018; 03/11/2019; 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR