MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD PHASE III BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see reports: 3002806535-2017-00750.Concomitant medical products-unknown oxford phase iii prosthesis unk part/lot; unknown oxford phase iii prosthesis unk part/lot.(b)(6).Report source, literature - j.Knifsund1, j.Hatakka, h.Keemu, k.Mäkelä, m.Koivisto, t.Niinimäki, md (2017).Unicompartmental knee arthroplasties are performed on the patients with radiologically too mild osteoarthritis.Scandinavian journal of surgery, the finnish surgical society 2017.Page 2.Doi: https://doi.Org/10.1177/1457496917701668.The reported event was unable to be confirmed due to limited information received from the customer.A review of device history records (dhr) was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Not returned to manufacturer.

Event Description

It was reported in a journal article that 6 revisions due to intra-operative fracture or technical failure in the primary operation were performed.No further information is available at this time.

• Brand Name: UNKNOWN OXFORD PHASE III BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6789825
• MDR Text Key: 82577099
• Report Number: 3002806535-2017-00753
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2017

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
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention