MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR RT SZ 4; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150401204
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Attune cementless femur revised today.This had been identified as part of a recall due to the sizing on the implant and box not matching the actual dimensions ie it said size 4 but it was actually a size 5.This had been raised several months ago but patient has recently been complaining of pain, hence the revision.Doi: on (b)(6) 2023.Doe: on (b)(6) 2024.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/08/2022.3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 31/07/2032.5) ifu reference: ifu-0902-00-870.H11 additional narrative: added: b5, e1 (unk) corrected: e1 (hospital).
Event or Problem Description
Additional information was received: 1.Was there any surgical delay related to the event? if yes, what is the duration of the delay? no.2.Was there any patient harm/consequence related to the event? required revision surgery due to loosening.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information provided, "attune cementless femur revised today.This had been identified as part of a recall due to the sizing on the implant and box not matching the actual dimensions ie it said size 4 but it was actually a size 5.This had been raised several months ago but patient has recently been complaining of pain, hence the revision." the product was not returned to depuy synthes for evaluation and no additional evidence of implant loosening was provide, therefore, implant loosening could not be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection could not be completed.However, review of previous complaints and review of the device history records confirmed this lot 3883327 was in scope of a product recall for size 5 components packaged and labeled as size 4.A previous investigation by the manufacturing site under pi-16802599008124436 ((b)(4)), reported the size 5 component was mis-etched and packaged as a size 4.Based on the previous and current investigation findings, the product issue addressed in the depuy synthes quality system that resulted in a recall could be a contributing factor to the reported event, however a direct correlation to the reported implant loosening and adverse events could not be established.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/08/2022.3) any anomalies or deviations identified in dhr: nr-0199414 is related to another confirmed complaint ((b)(4)) for a non-conformance that led to the recall of lot 3883327.There is no direct correlation between this nonconformance and the failure mode of the current complaint ((b)(4)), however the nonconformance issue could be a contributing factor.4) expiry date: 31/07/2032.5) ifu reference: ifu-0902-00-870.

• Brand Name: ATTUNE FEM POR CR RT SZ 4
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19709202
• Report Number: 1818910-2024-14896
• Device Sequence Number: 14246979
• Product Code: MBH
• UDI-Device Identifier: 10603295041474
• UDI-Public: (01)10603295041474(10)3883327(17)320731
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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: 150401204
• Device Lot Number: 3883327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 09/05/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/12/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown