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

Model Number	1012-04-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patients femoral head and liner were previously replaced on (b)(6) 2021.Surgeon noticed signs of trunionosis while cleaning out the joint.Patient later returned showing signs of infection.Surgeon removed the components and implanted a prostalac.Surgeon would like the trunnion examined on the stem with a response letter of the findings.Doi: unk; dor: (b)(6) 2022 (left hip).Please see (b)(4) for the first revision.
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.
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
Patients femoral head and liner were previously replaced on (b)(6) 2021.Surgeon noticed signs of trunionosis while cleaning out the joint.Patient later returned showing signs of infection.Surgeon removed the components and implanted a prostalac.Surgeon would like the trunnion examined on the stem with a response letter of the findings.Doi: unk; dor: (b)(6) 2022 (left hip).Please see (b)(4) for the first revision.
Event or Problem Description
1.Was there a surgical delay because of this event? if yes, what is the duration of the delay? 2.Please confirm if other components explanted during revision surgery were depuy? please provide details.3.Please provide date of implantation.4.Please confirm if products revised on (b)(6), 2021 were depuy? kindly provide details.Reponse: 1)the patient had a revision surgery to replace the head and liner then another revision surgery to remove the components due to infection.I'm not sure if that qualifies as a delay.2)the cup explanted during surgery was a smith & nephew cup and liner.The head explanted was our head.I don't have records from the original surgery yet but the head removed from infection was 1365-40-720, lot# 9847668.3)as stated above i don't have records from the original surgery yet, i am still attempting to secure that.4)the products revised on (b)(6) 2021 are stated above.
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 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d10 and h6 (patient) by removing code foreign body reaction (e2316).
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.Corrected: d10.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for examination.Visual examination of the returned device did not identify a device issue.It cannot be determined that a device failure or malfunction contributed to reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13584614
• Report Number: 1818910-2022-03336
• Device Sequence Number: 5817676
• Product Code: KWA
• UDI-Device Identifier: 10603295000761
• UDI-Public: 10603295000761
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 02/23/2022

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: 1012-04-050
• Device Catalogue Number: 101204050
• Device Lot Number: 326708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 04/06/2022; 05/24/2022; 07/06/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/03/2022; 04/07/2022; 06/08/2022; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2013
• 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: DLT TS CER HD 12/14 40MM +5.0; DLT TS CER HD 12/14 40MM +5.0; TRI-LOCK BPS SZ 5 STD OFFSET; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 93 KG