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

Model Number 1218-87-354

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

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167); No Code Available (3191)

Event Date 10/23/2018

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

After review of medical record, patient was revised to address metallosis, elevated metal ions, pain, pain with activities and pain with walking, inflammation, fibrosis, edema and focal fibrogranulation tissue formation.Revision notes stated that cloudy yellowish material was obtained and the trunnion showed that it has some amount of dark staining and with osteolysis.Doi: (b)(6) 2008.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.Device history lot : a complaint database search and/or device manufacturing (dhr) reviews will not be performed.Per wi-3430 it has been determined that should related reports be identified a dhr review is not required.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9825460
• MDR Text Key: 188527165
• Report Number: 1818910-2020-07666
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 2570749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR