MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB AUG LM/RL SZ 5/6 10MM; KNEE TIBIAL TRAY ACCESSORY

Model Number	1523-05-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Joint Laxity (4526)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
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
Clinical adverse event received for weakness right knee contributing to giving way event is not serious and is considered mild.There is a remote possibility the event is related to device and is definitely related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020.(right knee).Treatment: physical therapy.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was stated that "pain with level walking = 8".
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATUN TIB AUG LM/RL SZ 5/6 10MM
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12189570
• Report Number: 1818910-2021-15451
• Device Sequence Number: 3802128
• Product Code: JWH
• UDI-Device Identifier: 10603295057604
• UDI-Public: 10603295057604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1523-05-102
• Device Catalogue Number: 152305102
• Device Lot Number: J1061P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 07/09/2021; 08/19/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 07/28/2021; 08/22/2021
• 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 CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 10MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB AUG LM/RL SZ 5/6 10MM; ATUN TIB AUG RM/LL SZ 5/6 10MM; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT (ZIMMER); ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 10MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB AUG LM/RL SZ 5/6 10MM; ATUN TIB AUG RM/LL SZ 5/6 10MM; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT (ZIMMER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 94