MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 7 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-04-070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the patient had a left asr hip performed back on (b)(6) 2009.The orthopedic surgeon that was performing the revision did not tell me much about this patient.From speaking with the pa, he said the patient was not complaining of pain so much, but more from a clunking noise and impingement feeling.From what i understood the patient was not worked up for blood ion levels, etc.If he was, i wasn't aware of the results.Both the surgeon and pa both were talking about this revision from the noise/impingement.Once the surgeon opened the patient up, he did say that he saw some signs of metal/dark tissue.After he knocked off the asr head, he showed me the dark tissue and metallosis he said was around the trilock stem trunnion.He said that the surrounding tissue was in good shape.He looked over the asr head and cup for large abrasions that he thought may have been creating that sound/ impingement, however there were no marks anywhere.He removed the cup using the zimmer explant system.He then reamed the acetabulum and implanted a 58 pinnacle multi-hole cup.He put in 4 screws and a 40x58 +4/10 degree liner.He left the trilock stem in place.We trialed with a 40 +1.5 head and implanted that head size in a ceramic ts head.He was happy with the stability and leg lengths.Doi: (b)(6) 2009.Dor: (b)(6) 2019, left hip.
Event or Problem Description
Revision notes stated that some discolored cystic tissue was noted.The joint fluid was gray in color.Trunnionosis was noted with minimal changes overall of the trunnion.Acetabular component was removed with minimal bone loss.
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.H10 additional narrative: h6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone injury (e20).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
Litigation record received.Patient alleges pain, excessive cobalt and chromium, abrasion, and emotional distress for economic loss as well as punitive damages.
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.H10 additional narrative: added: b5 and h6 (clinical code).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased and joint disorder (musculoskeletal system (e16).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 : 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: 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
After review of medical records, it was reported that the patient was revised for left hip failed metal on metal arthroplasty.It was also indicated that the patient presented with mechanical symptoms including grinding, minimal pain with significant dysfunction because of mechanical symptoms.Operative notes reported that surgeon removed any tissue that was stained with the metallosis.Trunnionosis was noted with minimal changes overall to the trunnion.

• Brand Name: TRI-LOCK BPS SZ 7 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: 11165017
• Report Number: 1818910-2021-00995
• Device Sequence Number: 3583612
• Product Code: KWA
• UDI-Device Identifier: 10603295000785
• UDI-Public: 10603295000785
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/23/2019

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 Model Number: 1012-04-070
• Device Catalogue Number: 101204070
• Device Lot Number: C1WDX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/18/2021; 03/02/2021; 03/16/2021; 06/22/2021; 07/11/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/25/2021; 03/03/2021; 03/23/2021; 07/08/2021; 07/13/2021
• 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: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; TRI-LOCK BPS SZ 7 STD OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR