MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887354

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Tissue Damage (2104); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 primary surgery was performed via tha (date of primary surgery was unknown).The surgeon recognized that dissociation and dislocation occurred at the patient¿s hip joint in (b)(6) 2019.Since it was also recognized that there was suspected armd, the revision surgery was performed on (b)(6) 2019.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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).The complaint was received into the company with the following comment: the primary surgery was performed via tha (date of primary surgery was unknown).The surgeon recognized that dissociation and dislocation occurred at the patient¿s hip joint in feb 2019.Since it was also recognized that there was suspected armd, the revision surgery was performed on mar 5th 2019 by replacing the stem (p/n: 134524000), the cup (manufactured by kyocera), the liner (p/n: 121887354), the head (962711000).The surgery was completed without a surgical delay.No further information is available.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The products shall be retained for future reference in secure location as per procedures unless specifically requested back by the complainant.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8447773
• MDR Text Key: 139689144
• Report Number: 1818910-2019-88304
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2019

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 Catalogue Number: 121887354
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/15/2019; 05/22/2019
• Supplement Dates FDA Received: 05/14/2019; 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 50