MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X12MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7426
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Additional 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.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
Female patient received a left knee revision to treat loosening of the tibial construct secondary to the cement coming into contact with the tibial sleeve preventing appropriate bone ingrowth with the porous surface.There was significant tibial bone loss.There was no reported product problem with the revised tibial insert.The procedure was completed without complications.Doi: 2013.Dor: (b)(6) 2022.Left knee.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint.In order to confirm loosening, a series of chronological x-rays is needed.No other defects were identified.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 (mre) was not performed.Added: d4 (expiry date), d10 (concomitant).

• Brand Name: UNIVERSAL STEM 115X12MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15952245
• Report Number: 1818910-2022-24980
• Device Sequence Number: 6561901
• Product Code: JWH
• UDI-Device Identifier: 10603295217893
• UDI-Public: 10603295217893
• 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: 2013
• 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
• Report Date (Section B): 12/09/2022

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 Expiration Date: 04/30/2022
• Device Model Number: 86-7426
• Device Catalogue Number: 867426
• Device Lot Number: 234356
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2012
• 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: DEPUY CMW 2G 20G.; LPS UNIV TIB HIN INS SM 12MM.; MBT REVISION CEM TIB TRAY SZ 2.; MBT TRAY SLEEVE POR M/L 37MM.; PALACOS R+G 1X40.; PFC*SIGMA/OV/DOME PAT 3PEG,35.; SROM NRH DIST AUG XS/S/MD 5MM.; SROM NRHFEM W/PIN SM LFT 66X62.; UNIV FEM SLEEVE CEM 20MM.; UNIVERSAL STEM 115X12MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female