MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 4 8MM; KNEE FEMORAL ACCESSORY

Model Number	1549-04-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for intraop bone fracture - femoral.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022, date of event: (b)(6) 2022, (right knee).Treatment: open reduction internal fixation.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
Event or Problem Description
Clinical notes and operative notes indicated that "on (b)(6) 2010, the patient had a right hybrid total hip arthroplasty to address osteoarthritis.The patient has a medical history that included cerebrovascular accident, and peripheral neuropathy.Depuy components were implanted during this procedure.(b)(6) 2022 patient is status post right hip and left knee replacement with right knee pain.Patient is reported to have a lot of contractures on the left side due to a previous stroke.Patient reported having a fall shortly after returning home after previous knee replacement and had some wound dehiscence which was treated nonoperatively.An aspiration was done that came back negative for infection.The surgeon reported that the patient has significant osteolysis around the femoral component and has some interface changes around the tibial component.On (b)(6) 2022, the patient had a revision right total knee arthroplasty, all components, and open reduction internal fixation distal femur fracture with cerclage wires and synthes large fragment screws, due to chronic infection.The indications for surgery included pain, redness and swelling around the knee.Inflammation markers are elevated.The surgeon drilled holes in the bottom of the insert for cement digitation.The surgeon used a bur on the implanted depuy components (off-label) the surgeon noted that there was a longitudinal crack in the dorsal cortex femur, which was stabilized with 3 cerclage wires and 2 screws.Depuy components were implanted along with depuy cement.".
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.H10 additional narrative: added: b5 and b7.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 : the device associated with this complaint was not returned for investigation.The photo investigation found nothing indicative of a device nonconformance.The investigation of the radiographs provided was unable to identify whether the wires and screws shown are manufactured by depuy synthes.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 POS FEM AUG SZ 4 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14083701
• Report Number: 1818910-2022-06560
• Device Sequence Number: 17472238
• Product Code: JWH
• UDI-Device Identifier: 10603295383048
• UDI-Public: 10603295383048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2022

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 Model Number: 1549-04-002
• Device Catalogue Number: 154904002
• Device Lot Number: HN1390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 04/26/2022; 07/18/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 04/21/2022; 04/27/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2018
• 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: ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 22MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 4 4MM; DEPUY/CMW 2G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White