MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 30MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-102
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Difficult to Advance (2920)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the surgeon over reamed 1mm for the femoral stem, and broached and trialed appropriately.The real femoral construct sat proud and would not fully seat.It sat proud 3mm.Due to this, the patient has a gap misbalance, and will not fully extend.The pressfit for this construct is too much.Unless the surgeon plans to break femurs to seat fully, it is very difficult if not impossible to seat fully like the trial construct sat.A surgical delay of 20 seconds was noted.Doe: (b)(6) 2020.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the dhr review revealed one piece was scrapped at the unload sinter operation.No other deviations or anomalies were observed.Corrected; h6 (patient).Removed not applicable code and replaced with no code available (3191) to capture prolonged surgery.
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.¿.

• Brand Name: ATUN FEM SLV M/L 30MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10176541
• Report Number: 1818910-2020-14193
• Device Sequence Number: 3297804
• Product Code: JWH
• UDI-Device Identifier: 10603295436492
• UDI-Public: 10603295436492
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1511-01-102
• Device Catalogue Number: 151101102
• Device Lot Number: HX0154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/22/2020; 08/07/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 06/23/2020; 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL INSERT; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL INSERT
• Patient Age: 49 YR