MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE PATELLA

Catalog Number UNK KNEE PATELLA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Discomfort (2330); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/18/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient received implant on (b)(6) 2017.Postoperatively there were patella subluxation which were treated conservatively.As discomfort did not get better and the voluntary depuy recall came up the implant was revised on (b)(6) 2018.Patient´s health insurance is now claiming for reimbursement.".

• Brand Name: UNKNOWN KNEE PATELLA
• Type of Device: KNEE PATELLA
• 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9289893
• MDR Text Key: 165441616
• Report Number: 1818910-2019-114703
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE PATELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR