MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150610006

Device Problems Loss of or Failure to Bond (1068); Insufficient Information (3190)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received medical records (b)(6) 2018.Medical records indicate he received same day bilateral total knee replacements.Primary surgeon noted that the patient's left knee mcl tendon was injured intraoperatively, requiring suture anchor-type repair, and post-op knee bracing for recovery.Pc-(b)(4) addresses this event.Records also reported that his primary surgeon indicated patient was experiencing right knee pain and x-ray evidence supporting implant loosening of the right knee tibia.There was referral to another surgeon, and a post-operative dressing change note ((b)(6) 2017) indicating that a revision had taken place, but no date or operative revision records are currently available.Doi: (b)(6) 2015; dor: unknown; (right knee).

Manufacturer Narrative

(b)(4).Concomitant med products: attune rp tib base sz 6 cem; attune medial dome pat 41mm; attune ps rp insrt sz 7 10mm; attune ps fem rt sz 7 cem; smartset mv 40g - eo.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Patient code: no code available (3191) used to capture the medical device removal.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.

Event Description

Medical records received on 17 june 2019 were reviewed to identify patient harms/product issues on 04 december 2019.On (b)(6) 2015, the patient underwent total right knee arthroplasty due to degenerative arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with depuy knee system and depuy bone cement x 2.On (b)(6) 2017, the patient underwent a right knee revision due to loosening of the tibial component.The surgeon reported the tibial component was grossly loose, and removed using a saw, osteomes and a punch.He noted a well-fixed femoral component which was removed with minimal one loss.The surgeon indicated the patella was well-fixed with some debonding around the periphery.The patient was implanted with a competitor system and there were no complications to the procedure.Doi: (b)(6) 2015, dor: (b)(6) 2017, (rt knee).

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. (no code available (3191) is used to capture the device revision or replacement).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).Investigation summary : update 21-jan-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Visual examination of the provided photographs confirmed the reported event.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : dhr review: product code 150610006, work order (b)(4) was manufactured on 21 may 2015.(b)(4) parts were manufactured per specification and all raw materials met specification.There were no items identified in relation to the above parameters for these process steps during the investigation of this lot number relating to the complaint failure mode.

• Brand Name: ATTUNE RP TIB BASE SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7597558
• MDR Text Key: 110939275
• Report Number: 1818910-2018-62101
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150610006
• Device Lot Number: 8116107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM RT SZ 7 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR