MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL RT SZ 8 CEM; KNEE FEMORAL

Model Number 1504-40-208

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

Clinical adverse event received for patellar clunk.Event is serious and is considered moderate.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2020.Date of event: (b)(6) 2022.(right knee).Treatment: no intervention documented; awaiting scope.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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.H10 additional narrative: added: b5, d10 (concomitant med products), h6 health effect - clinical code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 health effect - impact code.

Event Description

Medical records received.On 09/18/2020 the patient had a revision right total knee arthroplasty, depuy components, including depuy patella and depuy cement, was used during this procedure.On 09/28/2022 medical records note the patient has had some increased grinding and crepitation around the right knee.The patient has some groin pain, which may be from the hip or knee.The physical examination notes ¿a little bit of thickening here¿ in the right knee.There is varus and valgus laxity in the knee.There is noticeable crepitation and patellar clunk.The patient reports feeling the knee catching which causes their quad to feel as though it wants to give.The patient is noted to be a good candidate for arthroscopic debridement, though there was no mention of one being scheduled.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was received for examination.Based on the visual analysis of the provided photographic evidence for device, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.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 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: ATTUNE CRS FEMORAL RT SZ 8 CEM
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15587142
• MDR Text Key: 306643970
• Report Number: 1818910-2022-20167
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042310
• UDI-Public: 10603295042310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-40-208
• Device Catalogue Number: 150440208
• Device Lot Number: J72F34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• 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
• Treatment: ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 14MM; ATTUNE CRS RP INSRT SZ 8 14MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 8MM; ATUN FEM SLV M/L 40MM HALF POR; ATUN TIB SLV M/L 53MM FULL POR; DEPUY/CMW 2G; DEPUY1 GENTAMICIN CEMENT 40G
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White