MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX60OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-460

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: ( b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.Initial reporter occupation: medical professional provided until plaintiff information is received.(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

Pinnacle medical records received.After review of medical records patient was revised to addressed mild to moderate adverse local tissue response with no frank necrosis of tissues outside of the joint nor pseudotumor formation.Operative notes indicated pain, elevated chromium and cobalt levels, taper of the head on to the trunnion had quite a bit of corrosion.Doi: (b)(6) 2008; dor: (b)(6) 2020 (right 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 (dhr) reviews will not be performed even when product/lot information is known.Per wi-3430 it has been determined that should related reports be identified a dhr review is not required.

• Brand Name: PINNACLE MTL INS NEUT40IDX60OD
• 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: 10829186
• MDR Text Key: 215916144
• Report Number: 1818910-2020-24419
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Model Number: 1218-87-460
• Device Catalogue Number: 121887460
• Device Lot Number: 2347174
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 60MM; TRI-LOCK BPS SZ 6 HI OFFSET; 12/14 ARTICUL 40MM M SPEC+5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 60MM; TRI-LOCK BPS SZ 6 HI OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR