MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 6 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-14-060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hearing Impairment (1881); Synovitis (2094); Ambulation or Postural Difficulties (2544); Limb Fracture (4518); Swelling/ Edema (4577)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Pinnacle litigation records received.Records alleges serious injury, economic loss and pain.Doi: (b)(6) 2009 ,dor: (b)(6) 2020 left hip.Update ad (b)(6) 2021 pfs and medical records received.In addition to what previously alleged, pfs alleges inability to walk, hearing loss/ringing ears, dry mouth and eyes, and high metal ions however laboratory result showed below normal level.After review of medical records patient was revised was due to periprosthetic fracture, wear and synovitis.Upon incision there was significant synovitis with a degree of mild metallosis gray staining of the portion of the soft tissues.In course of the liner removal there were normal abrasive marking made in the extracted component.
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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : updated 14-oct-2022.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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Medical records reviewed: litigation pfs alleges back, groin and hip pain; inability to walk for more than ¼ mile without having to sit due to pain; high metal ion content; hearing loss; ringing in ears; dry mouth and eyes, beginning in 2019.On (b)(6) 2005, primary right total hip replacement performed to address degenerative arthritis.Depuy pinnacle metal-on-metal uncemented hip replacement with aml press-fit stem implanted without complications.Implant log sticker sheet for primary right hip procedure on page 31 of records.On (b)(6) 2009, patient received a left total hip replacement performed to address degenerative arthritis.Depuy pinnacle metal-on-metal uncemented hip replacement with trilock press-fit stem implanted, without intraoperative complications.Patient reportedly had a normal blood loss consistent with post-op hip replacement, but experienced an acute drop of his hematocrit, but remained hemodynamically stable without any reported interventions.He had post-operative atelectasis which he recovered from with "appropriate pulmonary care and incentive spirometry".On (b)(6) 2020 lab result cobalt, plasma 4.5 ug/l high result.On (b)(6) 2020, patient admitted for revision treatment of left total hip wear, progressively severe pain, and synovitis, with conversion from metal-on-metal to ceramic on polyethylene.No complications.Mri on (b)(6) 2020 found fluid around the trochanters, but no evidence of soft tissue mass or pseudotumor.(b)(6) 2020 revision of right total hip to address metallosis and elevated cobalt and chromium, with conversion from depuy metal-on-metal head-liner to ceramic on polyethylene head-liner.Surgeon identified grayish stained periarticular tissues and evidence of corrosion fretting within the trunnion femoral head region.Stem and cup were well-fixed.No complications were reported.On (b)(6) 2021 lab results chromium, plasma 1.7 ug/l and cobalt, plasma <1.0 ug/l.

• Brand Name: TRI-LOCK BPS SZ 6 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 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12933971
• Report Number: 1818910-2021-27223
• Device Sequence Number: 17382912
• Product Code: KWA
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

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 Expiration Date: 08/31/2019
• Device Model Number: 1012-14-060
• Device Catalogue Number: 101214060
• Device Lot Number: D2RJR1
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 10/14/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/12/2021; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2009
• 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: 12/14 ARTICUL 40MM M SPEC+1.5; 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM; PINNACLE SECTOR II CUP 56MM; TRI-LOCK BPS SZ 6 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 126 KG