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

Model Number 1513-10-110

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

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 patient had revision of rt tka (b)(6) 2018.Revision of the femoral components (b)(6) 2021.The femur was reamed to the 8th mark and prepped for a 12 stem.Broached up to a 40 femoral sleeve with 8mm distal augments.During trialing it was evaluated that the femoral trial construct did sit down.The decision was made to proceed with the construct trialed and was assembled appropriately on the back table by the surgeon.It is noted that the 40 sleeve is not recommended to be used with a 3 crs femur but was engaged with no rotation in sleeve femoral construct.The 12 x 110 stem was attached and implanted.During cementing and implantation, the femoral construct would not go down and the surgeon extracted the implant and put in the construct with a 10x110 stem.This construct also set proud and would not go completely down.It is noted that the anterior bone is absent and not restricting the component from advancing.The surgeon then extracted the femoral components prior to cement hardening.The femur was re prepped and a trial assembled and trialed for a 35 sleeve with 4mm distal augments and 12 stem.This construct is what was put in.It is noted by the surgeon that he feels this is why the femur may have broke in the first revision case as the prepping for the femoral construct trial did not prep appropriately for implants.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

Event Description

Questions: a.Was there any adverse consequences that affected the patient because of the reported event? b.The reported product "154900103" is invalid in ecm and as400.Please provide valid product and/or lot number of the product.C.Please clarify if the trials played a part in the seating errors.D.Please provide product and lot number of the 12x110 stem.Answers for your questions: a.Not that the rep has been informed of c.In the copied replied statement it is clearly noted that the trial construct was confirmed to sit down.

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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATUN PRESSFIT STR STEM10X110MM
• Type of Device: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11737039
• MDR Text Key: 247680396
• Report Number: 1818910-2021-08978
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295043492
• UDI-Public: 10603295043492
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1513-10-110
• Device Catalogue Number: 151310110
• Device Lot Number: J49T74
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL RT SZ 3 CEM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE DIST FEM AUG SZ 3 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM10X110MM; UNKNOWN KNEE IMPLANT; ATTUNE CRS FEMORAL RT SZ 3 CEM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE DIST FEM AUG SZ 3 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM10X110MM; UNKNOWN KNEE IMPLANT