MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

Catalog Number UNK HIP STEM TRI-LOCK

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

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 11/03/2020

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

The patient was revised due to groin pain and higher ion levels.Doi: (b)(6) 2009, dor: (b)(6) 2020, affected side: 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 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 device history record (dhr) review, was not possible because the required lot code(s) was not provided.

• Brand Name: UNK HIP FEMORAL STEM TRI-LOCK
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10852857
• MDR Text Key: 216674477
• Report Number: 1818910-2020-24762
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

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 Catalogue Number: UNK HIP STEM TRI-LOCK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 40MM X 1.5 METAL HEAD; PINNACLE MTL INS NEUT40IDX56OD; TRILOCK STEM; 40MM X 1.5 METAL HEAD; PINNACLE MTL INS NEUT40IDX56OD; TRILOCK STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 126