MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-04-030

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Physical Asymmetry (4573)

Event Date 03/31/2021

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.

Event Description

Subject id: (b)(4).Study: (b)(4).Clinical notification received for revision of right total hip to address femoral stem loosening/subsidence and leg length discrepancy date of implantation: (b)(6) 2014.Date of revision: (b)(6) 2021.(right hip).Treatment: revision of the femoral stem, head, and liner; cup retained.

Event Description

After review on medical records, it was stated that on (b)(6) 2021, the patient had a right total hip revision to address mechanical complications, unequal leg length.The indications for surgery noted the patient had a gait abnormality, subsidence of the hip stem, and leg length discrepancy 2 cm.During the procedure the surgeon observed that the stem had subsided, but was well fixed to the bone.Depuy liner was used with competitor components during this procedure.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TRI-LOCK BPS SZ 3 STD 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: 11849267
• MDR Text Key: 251438950
• Report Number: 1818910-2021-10688
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000747
• UDI-Public: 10603295000747
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-04-030
• Device Catalogue Number: 101204030
• Device Lot Number: 527505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX LIP LNR 32IDX52OD; ARTICUL/EZE BALL 32 +13 BLK; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 52MM; TRI-LOCK BPS SZ 3 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 93