MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 7 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-708
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
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
Revision of left attune cr rp primary knee, with date of primary surgery (b)(6) 2017.Original implants were size 7 left cr femur, size 7 rp tibial baseplate, size 7, 8mm cr rp insert, no patella resurfacing at index procedure.Cmwii in separate mixes for tibia and femur had been used.Patient xrays looked fine post op, at 6 months showed some rll, then at 2.5 years patient started to feel severe pain in both sides, and xrays showed loosening on both femurs query of some cysts on tibia also.Left side was most painful, so was first to be revised.Femur came off very easily, with fibrous membrane surrounding the bone, and cysts around the femoral lug holes.Tibia was more well fixed, but the cr rp poly had severe wear with lots of pitting all over the articulating surface and signs of backside wear underneath.Tibial tray was loose, but not as loose as the femur.No signs of any loose bodies in the joint.No confirmed infection.
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.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported poly wear.No evidence was found of product error as a contributing factor to the abrasive wear, and the need for corrective action was not indicated.Depuy 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.Device history lot: product code 151630708, work order (b)(4) was manufactured on 24-may-2017.16 parts were manufactured per specification and all raw materials met specification.There was 1 scrap part associated with this lot.On review of the scrap reason it was found that this part had been scrapped for ¿rh cond f & l (right hand condyle form & location)¿, where the right-hand top side of the part was out of specification.Therefore, this scrap reason is unrelated to the failure mode of this pc.There was no non-conformances or deviations associated with this lot.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported poly wear.No evidence was found of product error as a contributing factor to the abrasive wear, and the need for corrective action was not indicated.Depuy 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.Update 13-jan-2021: the investigation was re-opened upon receipt of additional information.The new information does not affect the previous investigation.Device history lot: product code 151630708, work order (b)(4), was manufactured on 24-may-2017.(b)(4) parts were manufactured per specification and all raw materials met specification.There was 1 scrap part associated with this lot.On review of the scrap reason it was found that this part had been scrapped for ¿rh cond f & l (right hand condyle form & location)¿, where the right-hand top side of the part was out of specification.Therefore, this scrap reason is unrelated to the failure mode of this pc.There was no non-conformances or deviations associated with this lot.

• Brand Name: ATTUNE CR RP INSRT SZ 7 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10662391
• Report Number: 1818910-2020-21917
• Device Sequence Number: 3960656
• Product Code: NJL
• UDI-Device Identifier: 10603295048015
• UDI-Public: 10603295048015
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1516-30-708
• Device Catalogue Number: 151630708
• Device Lot Number: 8537013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/09/2020; 11/16/2020; 12/17/2020; 01/13/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/22/2020; 11/17/2020; 12/28/2020; 01/18/2021
• 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 CR FEM LT SZ 7 CEM.; ATTUNE RP TIB BASE SZ 7 CEM.; DEPUY CMW 2G 20G.; DEPUY CMW 2G 20G.; UNK CEMENT CMW .; UNK CEMENT CMW .
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR