MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign - event occurred in (b)(6).Concomitant medical products: medical product: oxford uni femoral sm catalog #: 154600 lot #: j6397014.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00774.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a hospital ordered oxford tinobium implants, however received the wrong implants.Subsequently, the surgery was completed with competitors products.Issue caused 31-60 minute delay.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 or Problem Description
It was reported that a hospital ordered oxford tinobium implants, however received the wrong implants.Subsequently, the surgery was completed with competitors products.Issue caused 31-60 minute delay.

• Brand Name: OXF UNI TIB TRAY SZ B LM PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9138556
• Report Number: 3002806535-2019-00773
• Device Sequence Number: 19506697
• Product Code: NRA
• UDI-Device Identifier: 05019279388868
• UDI-Public: 05019279388868
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154720
• Device Lot Number: 6568743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization