MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-04-030

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/12/2020

Event Type  malfunction  

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 Description

It was reported that the surgeon broached up to a 3 broach and implanted a size 3 thrilock std.It sat proud and after rebroaching it still sat proud.He then removed the stem and broached up to a 4 then implanted a new size 3.This delayed the case about 5-10 minutes but was not detrimental to the outcome.I will wash and return the implant in question.Doe: (b)(6) 2020 affected site: unknown.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> 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.H10 additional narrative: added: h6 (patient and device codes) h6 patient code: no code available (3191) used to capture the prolonged surgery and insufficient information.H6 device code: no code available (3191) used to capture the functional: trial does not replicate the implant.

• Brand Name: TRI-LOCK BPS SZ 3 STD OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10097531
• MDR Text Key: 192466118
• Report Number: 1818910-2020-12767
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000747
• UDI-Public: 10603295000747
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 1012-04-030
• Device Catalogue Number: 101204030
• Device Lot Number: J65T56
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRI-LOCK BPS BROACH SZ 3; TRI-LOCK BPS SZ 3 STD OFFSET; TRI-LOCK BPS BROACH SZ 3; TRI-LOCK BPS SZ 3 STD OFFSET