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 Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Emotional Changes (1831); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed to remove asr hip and sleeve.Metal ion levels were elevated.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(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
Revision completed to remove asr hip and sleeve.Metal ion levels were elevated.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: b5.
Event or Problem Description
Affected side: left hip.
Event or Problem Description
Patient alleges pain, discomfort, permanent injuries, emotional distress, disability, disfigurement, economic 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.E3 initial reporter occupation: lawyer.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
Patient alleges squeaking sound coming from hip, anxiety, extreme stress, fear, emotional distress, lesion, and pseudotumor.Patient was replaced with poly liner and ceramic head.Doi: (b)(6) 2009, dor: jan 26, 2022 (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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: e3 initial reporter occupation: lawyer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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: b1 (is product problem), b5, b7, d10, g4, h4 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, d1, d2, d4 and h6 (device code).
Event or Problem Description
After review of medical records, it was noted that the patient was revised due to failed tha.Operative notes reported that copious dark fluid was encountered.There was extensive staining of the synovium from multiple different altr lesions.The trunnion was noted to have some corrosion.There was extensive metallosis involving the insertion of the iliopsoas on the lesser trochanter.There was necrotic tissue.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: update 05-aug-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.

• 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 dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13480755
• Report Number: 1818910-2022-02486
• Device Sequence Number: 19370282
• Product Code: KWA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/08/2022
• 2 Devices were Involved in the Event: 1 2

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: 08/01/2018
• Device Model Number: 1012-14-030
• Device Catalogue Number: 101214030
• Device Lot Number: C2VAF1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/11/2022; 06/21/2022; 07/07/2022; 07/19/2022; 08/05/2022; 09/19/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/14/2022; 07/06/2022; 07/08/2022; 08/04/2022; 08/09/2022; 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2008
• 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: ADAPTER SLEEVES 12/14 +2; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; ASR UNI FEMORAL IMPL SIZE 49; ASR UNI FEMORAL IMPL SIZE 49; TAPER SLEEVE ADAPTER 12/14 +2; UNK HIP ACETABULAR CUP ASR; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG