MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X20MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7419
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the devices are reported under (b)(4) as the patient experienced adverse events on different days with the same devices.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
The patient was revised due to aseptic loosening.Doi: unknown, dor: (b)(6) 2021, unknown knee side.
Additional Manufacturer Narrative
(b)(4) the devices are reported under (b)(4) as the patient experienced adverse events on different days with the same devices.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
The patient was revised due to aseptic loosening.Doi: unknown, dor: (b)(6) 2021, unknown knee side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed, there is no sufficient evidence in order to confirm the complaint.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: UNIVERSAL STEM 75X20MM 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): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13534866
• Report Number: 1818910-2022-02828
• Device Sequence Number: 5075525
• Product Code: JWH
• UDI-Device Identifier: 10603295217855
• UDI-Public: 10603295217855
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 86-7419
• Device Catalogue Number: 867419
• Device Lot Number: 443282
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• 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: ALLOSOURCE MISCELLANEOUS TISSUE 104682109; LPS DISTAL FEM COMP XXSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 45MM; LPS UNIV TIB HIN INS XXSM 18MM; MBT REV TIB TRAY SIZE 2 25MM; MBT TRAY SLEEVE POR M/L 61MM; STRYKER CEMENT; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; UNIVERSAL FEM SLV FUL POR 34MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 123 KG