MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS FEMORAL COCR LARGE; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in the (b)(6).Concomitant medical products: medical product: oxf uni cmntls tib sz f rm, catalog #: 166581, lot #: unknown; medical product: oxf anat brg rt lg size 4 pma lrg sz 4 , catalog #:159583, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00637, 3002806535-2019-00638.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported by the hospital that a patient underwent an initial right knee arthroplasty on (b)(6) 2008.Subsequently, a revision procedure was performed on (b)(6) 2019 due to lateral compartment osteoarthritis and instability caused by the anterior cruciate ligament deficiency (acld).
Event or Problem Description
It has been reported by the hospital that a patient underwent an initial right knee arthroplasty on (b)(6) 2008.Subsequently, a revision procedure was performed on (b)(6) 2019 due to lateral compartment osteoarthritis and instability caused by the anterior cruciate ligament deficiency (acld).
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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.

• Brand Name: OXFORD PKS FEMORAL COCR LARGE
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8845566
• Report Number: 3002806535-2019-00636
• Device Sequence Number: 290359
• Product Code: NRA
• UDI-Device Identifier: 05019279388097
• UDI-Public: 05019279388097
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010014/S028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 86