MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN OXFORD KNEE; KNEE PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (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 as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects: under possible adverse effects: number 13 states, dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions (b)(4).Clinical outcomes and risks of single-stage bilateral unicompartmental knee arthroplasty via oxford phase iii.Chinese medical journal, 128(21), 2861-2865.Doi:10.4103/0366-6999.168042.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.(b)(4).This report is being submitted late as it has been identified in remediation.(b)(4).Product location unknown.

Event Description

Information was received based on review of a journal article entitled, "clinical outcomes and risks of single-stage bilateral unicompartmental knee arthroplasty via oxford phase iii".The article addresses that a dislocation was noted on x-ray of patients who underwent a single-stage or two-stage medial uka with oxford product.The number of patients with observed implant dislocation post-op is unknown and it is unknown if any treatment was required.There has been no further information provided and the patients outcome is unknown.

• Brand Name: UNKNOWN OXFORD KNEE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6953280
• MDR Text Key: 89456405
• Report Number: 0001825034-2017-08867
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• 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