MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM10X110MM; KNEE STEMS

Catalog Number 151310110

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6).2023, the revision surgery was performed via tka with the stem in question.When assembling the stem in question, it moved poorly and stopped midway, so another stem was used instead.An investigation was requested due to a defect in the stem in question.In addition, the primary surgery (date unknown) was performed using another company's product; no jj product was used.No further information is available.

Manufacturer Narrative

Product complaint(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that on (b)(6) 2023, the revision surgery was performed via tka with the stem in question.When assembling the stem in question, it moved poorly and stopped midway, so another stem was used instead.An investigation was requested due to a defect in the stem in question.In addition, the primary surgery (date unknown) was performed using another company's product; no jj product was used.No further information is available.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device does not found sings of damage or defects at the atun pressfit str stem10x110mm.A dimensional inspection was performed for the device and met specifications.The overall complaint was not confirmed as the atun pressfit str stem10x110mm was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? dwg-1151310160 rev.B current.Dimensional inspection: specified dimensions: device length: 110.00 +/- 0.25 mm.Device width: 11.25 +/- 0.13 mm.Measured dimensions: device length: 110.11 mm (complies).Device width: 11.23 mm (complies).Device used: digimatic caliper cd78619.Device history lot: a manufacturing record evaluation was performed for the finished device product description: atun pressfit str stem10x110mm product code: 151310110 lot number: j4278u and no non-conformances or manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device product description: atun pressfit str stem10x110mm product code: 151310110 lot number: j4278u and no non-conformances or manufacturing irregularities were identified.

• Brand Name: ATUN PRESSFIT STR STEM10X110MM
• Type of Device: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18317619
• MDR Text Key: 330366529
• Report Number: 1818910-2023-25227
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295043492
• UDI-Public: 10603295043492
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

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 Catalogue Number: 151310110
• Device Lot Number: J4278U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/19/2024; 02/26/2024
• Supplement Dates FDA Received: 01/22/2024; 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1