MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 8 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204080
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total hip replacement procedure, the doctor wasted an implant and asked to verify if the sizing on this specific implant was correct.Surgery was not delayed and was successfully completed.There was no patient consequence.
Additional Manufacturer Narrative
Product complaint #(b)(4).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 the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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).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.H11 additional narrative: added: b5, e1 (hospital) 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 and stated that the implant size was smaller than normal.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: 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.H11 additional narrative: added: d4 (lot, expiry date), d9, h4.Corrected: d4 primary udi number.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).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 doctor wasted an implant and asked us to verify if the sizing on this specific implant was correct.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found it was returned outside the sterile packaging.No cosmetic defects were observed on the surface of the device.A dimensional inspection was performed and met specifications.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the tri-lock bps sz 8 std offset would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The following drawings reflecting the current and manufactured revisions were reviewed: dwg-101204080 rev f current, rev e manufactured.Dimensional inspection: drawing: dwg-101204080 rev e manufactured.Feature: length, thickness, neck diameter.Specification: length: 132.00 +/-1.00, thickness: 12.78 +/- 0.38, neck diameter: 12.850 +/- 0.025.Measured dimension: length: 132.06 mm, thickness: 12.73 mm, neck diameter: 12.870 mm.Result: conforming measurement device: caliper mitutoyo cd-6" asx id# (b)(4).Device history lot 1) quantity manufactured: (b)(4), 2) date of manufacture: 08/27/2020, 3) any anomalies or deviations identified in dhr: none.4) expiry date: 07/31/2030.5) ifu-0902-00-701.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Corrected: h3.

• Brand Name: TRI-LOCK BPS SZ 8 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20420428
• Report Number: 1818910-2024-21319
• Device Sequence Number: 8209742
• Product Code: LPH
• UDI-Device Identifier: 10603295000792
• UDI-Public: (01)10603295000792(17)300731(10)J88N16
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101204080
• Device Lot Number: J88N16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 11/06/2024; 03/10/2025; 03/11/2025; 07/03/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/24/2024; 11/07/2024; 03/11/2025; 03/12/2025; 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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: TRI-LOCK BPS SZ 8 STD OFFSET.
• Patient Age: 62 YR
• Patient Sex: Male