MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 1 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-010
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported as removal of stem and head due to stem subsidence.Replaced liner as well.Replaced stem with a summit, and a new head and liner.It was also indicated that there was loosening of the stem at the bone to implant interface.Doi: (b)(6) 2018, dor: (b)(6) 2020, affected side: 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.

• Brand Name: TRI-LOCK BPS SZ 1 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: 10690391
• Report Number: 1818910-2020-22591
• Device Sequence Number: 14165405
• Product Code: KWA
• UDI-Device Identifier: 10603295001034
• UDI-Public: 10603295001034
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012-14-010
• Device Catalogue Number: 101214010
• Device Lot Number: HD7278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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 +4 NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +1.5; TRI-LOCK BPS SZ 1 HI OFFSET; ALTRX +4 NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +1.5; TRI-LOCK BPS SZ 1 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR