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

Catalog Number	101204050
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: (b)(6).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Litigation complaint received ad 17 jul 2023.On (b)(6), 2022 patient underwent a revision due to adverse local tissue reaction of metal on metal total hip arthroplasty.Operatives notes indicated there was quite a bit of corrosion on the taper of the stem, which was cleaned off.Metallosis debris was also noted.Doi: (b)(6), 2009.Dor: (b)(6), 2022.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.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.
Event or Problem Description
Additional information was received: plaintiff was implanted with a mom pinnacle system in plaintiff's hip on (b)(6) 2009.The patient suffered heavy metal poisoning, injury and requiring surgery to remove the defective hip replacements.Plaintiff was forced to undergo surgical removal due to heavy metal poisoning on (b)(6) 2022.As a direct and proximate result of the defective pinnacle hip, plaintiff was required to undergo surgical removal of the defective system, suffered injury to his muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.As a direct and proximate result of the defective pinnacle hip replacement, plaintiff suffered injuries, including but not limited to significant pain, injury caused by metallosis, metal wear, and metal poisoning.Plaintiff expects to continue suffering such injuries in the future because of the injuries received from the pinnacle.As a direct and proximate result of the defective pinnacle, plaintiff experienced emotional trauma and distress and is likely to experience emotional trauma and distress in the future.

• Brand Name: TRI-LOCK BPS SZ 5 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17396834
• Report Number: 1818910-2023-15230
• Device Sequence Number: 12655313
• Product Code: LPH
• UDI-Device Identifier: 10603295000761
• UDI-Public: 10603295000761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 101204050
• Device Lot Number: C39AK1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2008
• 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: 12/14 ARTICUL 40MM M SPEC+5; APEX HOLE ELIM POSITIVE STOP; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 60MM; PINNACLE MTL INS NEUT40IDX60OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male