MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On tuesday, (b)(6), at (b)(6) hospital, dr.(b)(6) revised the left hip of a patient who had a left primary hip arthroplasty implanted by dr.(b)(6) at (b)(6) hospital in 2016.Patient presented in dr.(b)(6) clinic with left anterior thigh pain.Dr.(b)(6) elected to remove the sz 5 trilock bps that was in the patient to treat for the pain.Dr.(b)(6) removed the 32 +9 biolox delta femoral head with a tamp.Dr.(b)(6) then began removing the stem using a combination of rigid and flexible osteotomes as well as the depuy screw in femoral stem inserter and associated slap hammer.While trying to remove the well fixed femoral stem dr.(b)(6) fractured the proximal femur.As a result, dr.(b)(6) chose to treat the patient with a competitor's revision stem.Dr.(b)(6) removed the primary liner and replace it with a sz 56x 36 +4 10 deg altrx liner to help improve biomechanics.There was no indication by anyone that the products did not perform as expected.No instrumentation broke during the case.There was no loosening of any components.Doi: 2016.Dor: (b)(6) 2021, left hip.
Additional 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 : for allegations of pain a device manufacturing (mre) review will not be performed even when product/lot information is known.Per (b)(4) , review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• Brand Name: TRI-LOCK BPS SZ 5 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12474680
• Report Number: 1818910-2021-20144
• Device Sequence Number: 14290164
• Product Code: KWA
• UDI-Device Identifier: 10603295001072
• UDI-Public: 10603295001072
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1012-14-050
• Device Catalogue Number: 101214050
• Device Lot Number: 650210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX LIP LNR 32IDX56OD; HIP BALL BIOLOX 32 +9 12/14; TRI-LOCK BPS SZ 5 HI OFFSET; ALTRX LIP LNR 32IDX56OD; HIP BALL BIOLOX 32 +9 12/14; TRI-LOCK BPS SZ 5 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR