MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-14-020

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026); Migration (4003)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/22/2020

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 primary surgery was performed on (b)(6) 2014 via tha for the patient¿s right hip joint.After the surgery, the patient had a pain because the stem (p/n: 101214020)¿s sinking toward valgus occurred, and this caused to form the pedestal at the distal point of the stem and the distal point of the stem touched cortex bone.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the stem, the liner (p/n: 122432052) and the head (p/n: 136532330) due to the pain.A cup was remained in the body.The revision surgery was completed with 210 minutes delay.The surgeon thought that this event was caused by a mistake of the choice of the stem¿s size at the primary surgery.No further information is available.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H10 additional narrative: added: b1 and h6 (patient code).H6 patient code: no code available (3191) used to capture the surgery prolonged.

• Brand Name: TRI-LOCK BPS SZ 2 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10120888
• MDR Text Key: 194058353
• Report Number: 1818910-2020-13234
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295001041
• UDI-Public: 10603295001041
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-14-020
• Device Catalogue Number: 101214020
• Device Lot Number: 440170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 32MM +9; PINN MAR ETO NEUT 32IDX52OD; TRI-LOCK BPS SZ 2 HI OFFSET; DELTA CER HEAD 12/14 32MM +9; PINN MAR ETO NEUT 32IDX52OD; TRI-LOCK BPS SZ 2 HI OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR