MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150411207
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Swelling (2091)
Date of Event	11/14/2018
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.(b)(4).
Event or Problem Description
Clinical adverse event received for frequent popping to posterolateral right knee, possible popliteus scarring.
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.(b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was 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 will be re-opened as necessary.

• Brand Name: ATTUNE FEM POR PS RT SZ 7
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8292428
• Report Number: 1818910-2019-82820
• Device Sequence Number: 1500647
• Product Code: JWH
• UDI-Device Identifier: 10603295042068
• UDI-Public: 10603295042068
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2019

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 Catalogue Number: 150411207
• Device Lot Number: 8898329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 02/05/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/01/2019; 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 100