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

Model Number	1012-14-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530)
Date of Event	08/04/2020
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
It was reported that the patient was revised to addressed pain and elevated metal ions level.The patient had left tha performed back in 2001.The patient had a trilock stem and pinnacle mom hip in.The surgeon wanted to remove the pinnacle mom components and put in a competitor product dual mobility construct.The surgeon removed the screw, metal liner and cup.He implanted the competitor construct and used our 28 mm ts ceramic head.Doi: 2001, dor: (b)(6) 2020, left hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :the information received will be retained for potential series investigations if triggered by trend analysis 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.
Additional 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.E3 initial reporter occupation: lawyer.
Event or Problem Description
After review of the medical records the patient was revised to address failed tha with metallosis and elevated metal ions resulting to hip pain.Operative note reported synovectomy, removal of debris and scar tissue.Lab result shows above 7ppb.Doi: (b)(6), 2009; dor: (b)(6) 2020; left hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary = > the information received will be retained for potential series investigations if triggered by trend analysis 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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative:  added: d6b corrected: d2b.

• Brand Name: TRI-LOCK BPS SZ 3 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10413811
• Report Number: 1818910-2020-18206
• Device Sequence Number: 5717069
• Product Code: LPH
• UDI-Device Identifier: 10603295001058
• UDI-Public: 10603295001058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2020
• 3 Devices were Involved in the Event: 1 2 3

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 Expiration Date: 10/31/2019
• Device Model Number: 1012-14-030
• Device Catalogue Number: 101214030
• Device Lot Number: D5LGM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/15/2020; 11/06/2022; 12/21/2022
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/16/2020; 11/21/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM -2; ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN MOM LINER 50MM; PINN SECTOR W/GRIPTION 50MM; PINN SECTOR W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; ARTICULEZE M HEAD 36 MM -2; PINN CAN BONE SCREW 6.5 MMX20 MM; PINN MOM LINER 50 MM; PINN SECTOR W/GRIPTION 50 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female