MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TIBIAL COMPONENT

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4) panzram b, bertlich i, reiner t, walker t, hagmann s, gotterbarm t (2017) cementless oxford medial unicompartmental knee replacement: an independent series with a 5-year-follow-up.Archives of orthopaedic and trauma surgery, july 2017, volume 137, issue 7, pp 1011¿1017, ttps://link.Springer.Com/content/pdf/10.1007/s00402-017-2696-9.Pdf (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review 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.

Event Description

Information received based on review of a journal article, entitled "cementless oxford medial unicompartmental knee replacement: an independent series with a 5-year-follow-up", by panzram, b.Et al.(2017) this complaint refers to the reported revision due to tibial plateau fracture 1 month after the initial procedure.It was revised to a cemented tibial component and orif.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• 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: 7199239
• MDR Text Key: 97566576
• Report Number: 3002806535-2018-00123
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/17/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention