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

Model Number	1012-04-010
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/27/2021
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
Compass case (b)(4) report: it was reported that the stem subsided.Implant loosening was also noted of the trilock component-noncemented.The sale rep was contacted by the surgeon that she had a trilock implanted some time ago that had subsided in one of her patients.She did say that the patient missed their post-op office visit.She showed back up with a painful hip.She explained the stem had subsided and she wanted to revise it to a stryker and have liners available for exchange for the pinnacle cup.The pinnacle liner was exchanged and the stem and head was revised to stryker.The ref: (b)(4) lot: 39030g pinnacle altrx liner 36mm/52mm was used to replace the old liner.The 52mm pinnacle porocoat shell ref:(b)(4) lot:c43763 was left in patient.Doi: (b)(6) 2016; dor: (b)(6) 2021; affected side: right 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: 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 1 STD 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: 12438024
• Report Number: 1818910-2021-19544
• Device Sequence Number: 3780530
• Product Code: KWA
• UDI-Device Identifier: 10603295000723
• UDI-Public: 10603295000723
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012-04-010
• Device Catalogue Number: 101204010
• Device Lot Number: 745560
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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 NEUT 36IDX52OD.; DELTA CER HEAD 12/14 36MM +5.; PINNACLE SECTOR II CUP 52MM.; TRI-LOCK BPS SZ 1 STD OFFSET.; ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +5; PINNACLE SECTOR II CUP 52MM; TRI-LOCK BPS SZ 1 STD OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR