MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-235
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Noiles femoral implant broken on the sleeve connection.Doi: (b)(6) 2018.Dor: (b)(6) 2022.Unknown side.
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).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 : the device associated with this complaint was received for examination.The photo investigation and visual examination of the returned device cannot confirm the reported allegation.The device was not found broken.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 (mrae) was not performed.
Event or Problem Description
Additional information received: a.Patient demographics the following are the types of patient demographics we require: relevant comorbidities, date of implantation (b)(6) 2018, date of revision (b)(6) 2022, operative side right, age at the time of the procedure 65, weight 120 kg, height 1,80m, and activity level.Active b.Excerpts from the clinical correspondence: please provide all correspondence relevant to the reported event for example: onset of symptoms, trauma, other devices, leg length discrepancy, gait patterns, medical investigations or any other issues the complainant feels important.The only thing we know is that the patient fell.
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 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical codes).

• Brand Name: UNIVERSAL FEM SLV DIS POR 40MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14192365
• Report Number: 1818910-2022-07386
• Device Sequence Number: 4447396
• Product Code: JWH
• UDI-Device Identifier: 10603295026327
• UDI-Public: 10603295026327
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-53-235
• Device Catalogue Number: 129453235
• Device Lot Number: HY9576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 05/04/2022; 06/30/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/05/2022; 05/07/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2018
• 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: LPS UNIV TIB HIN INS MED 12MM; LPS UNIV TIB HIN INS MED 12MM; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 29MM; SROM NRHFEM W/PIN MED RT 71X66; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 120 KG