MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN KNEE FEMORAL

Catalog Number UNK KNEE FEMORAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); No Code Available (3191)

Event Date 08/28/2018

Event Type  Injury  

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 Description

Revision related to traumatic patellar (tendon) mcl.

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Update: reportedly patient fell, with first occurrence involving complete rupture of her proximal patellar tendon, and then a second fall resulting in the disruption of her medial and lateral collateral tendons.Revising surgeon identified, on (b)(6)/2018, a complete avulsion of patellar tendon, with remaining attachment to tibial tubercle.He also noted that both the metal retinaculum and collateral ligament were torn, as well as the lateral retinaculum and collateral ligament.There was also a large hematoma present, observed upon opening the knee.Tibial tray and femur components were explanted (no evidence of loosening), and a stemmed hinged-knee construct was implanted.This was followed by a marlex mesh patellar tendon reconstruction.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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: UNKNOWN KNEE FEMORAL
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 6103142063
• MDR Report Key: 8045917
• MDR Text Key: 126377697
• Report Number: 1818910-2018-74770
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: 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 Weight: 79