MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 4 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number	1012-04-040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
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
While surgeon was trying to put the femoral stem in the femoral canal, the implant sat too tall versus the broach.Surgeon broached until rasp 4, put a 4 standard implant, and the stem was 6 mm higher than the trial.The surgeon removed the implant with a slap hammer, reamed again with broach size 4, tried to put back the femoral stem size 4 in the canal, and was still proud of 6 mm.He then removed the stem, and ask for an other size 4.
Additional Manufacturer Narrative
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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot hr3366.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: hr3366 device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : hr3366.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Corrected: g1 and h3.
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.H6 patient code: no code available (3191) used to capture the surgery prolonged and no signs, symptoms or patient involvement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 4 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8703548
• Report Number: 1818910-2019-96090
• Device Sequence Number: 1876349
• Product Code: KWA
• UDI-Device Identifier: 10603295000754
• UDI-Public: 10603295000754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/28/2019

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 Model Number: 1012-04-040
• Device Catalogue Number: 101204040
• Device Lot Number: HR3366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/25/2019; 06/25/2019; 09/24/2020; 11/20/2020
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/04/2019; 07/08/2019; 10/12/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1