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

Catalog Number	129453235
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/05/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Dr (b)(6) private (b)(6) 2018: primary (b)(6) 2012; this is not the first revision, patient presented with knee pain.Upon opening the knee the femoral component was found to be loose.The femoral bolt was found to be broken and was loose in the knee.The femoral adapter was also found be broken with the vagus angle correction ring of the adapter found loose in the posterior part of the knee.The remainder of the femoral adapter was stuck in the femoral sleeve and could not be removed.The well fixed femoral sleeve and stem was removed.The mbt revision tibia, sleeve and tibia stem was left in situ north and appeared to be well fixed.A new sigma tc3 size 5 femur and larger sleeve and new stem was inserted.Male patient; (b)(6) years old, (b)(6), 179cm and (b)(6) kg.Unknown_jrn: 1 x tc3 femur.Doi: may 08,2012; dor: jan 05,2018; unknown affected side no surgical delay.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 7227096
• Report Number: 1818910-2018-52299
• Device Sequence Number: 1158940
• Product Code: JWH
• UDI-Device Identifier: 10603295026327
• UDI-Public: 10603295026327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2018

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: 129453235
• Device Lot Number: E14HWA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 01/04/2018; 11/28/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/02/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 89