MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA SML SZ 4; UNICONDYLAR KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Receipt by User (1570); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Establishment name: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.
Event or Problem Description
Before opening the last layer of aseptic packaging (still sealed), it was found that there was a hair on the oxford phase 3 anatomic arcom bearing.The doctor used the same type of product with different thickness of 3mm to complete the operation.The operation was delayed for 10 minutes.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Then sales confirmed that root cause is due to the improper storage of the removed packaging and there was no issue with the product.Risk assessment: the reported event states foreign body found in with the device during the operation.The severity score associated with this failure mode is 4 ¿ permanent impairment of a body function or permanent damage to a body structure.The event also reports a delay of 10 minutes.The reported event is considered to be within the severity of the risk file.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
Event or Problem Description
Before opening the last layer of aseptic packaging (still sealed), it was found that there was a hair on the oxford phase 3 anatomic arcom bearing.The doctor used the same type of product with different thickness of 3mm to complete the operation.The operation was delayed for 10 minutes.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA SML SZ 4
• Common Device Name: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10619461
• Report Number: 3002806535-2020-00432
• Device Sequence Number: 19152991
• Product Code: NRA
• UDI-Device Identifier: 05019279786152
• UDI-Public: 05019279786152
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 159569
• Device Lot Number: 6599920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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
• Patient Age: 78 YR
• Patient Weight: 61