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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation (unavailable by hospital policy).Concomitant medical products: medical product: oxford ph3 cementless fem sz m, catalog #: 154926, lot #: s452411.Medical product: unknown oxford bearing component, catalog #: unknown, lot #: 3026952.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00525, 3002806535-2020-00526.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial surgery on (b)(6) 2003 (oxford pkr implanted).Subsequently, the patient was revised on (b)(6) 2020 due to progressive arthritis (vanguard ps plus stemmed baseplate implanted).

Event Description

It was reported that the patient underwent an initial surgery on (b)(6) 2003 (oxford pkr implanted).Subsequently, the patient was revised on (b)(6) 2020 due to progressive arthritis (vanguard ps plus stemmed baseplate implanted).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00525-1, 3002806535-2020-00526-1.Additional information: item numbers of oxford bearing & oxford tibial component received.Medical product: oxf anat brg lt sm size 6 pma, catalog #: 159543, lot #: 3026952.Medical product: oxf uni cmntls tib sz d lm, catalog #: 166576, lot #: s448225.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that initial surgery took place on (b)(6) 2003.Subsequently, the patient was revised on (b)(6) 2020 due to progressive arthritis.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00525-2, 3002806535-2020-00526-2.D11: medical product: unknown femoral component, catalog #: unknown, lot #: unknown medical product: unknown bearing component, catalog #: unknown, lot #: unknown correction: product tabs are updated as unknown, as it is stated that patient was revised to vanguard ps plus stemmed baseplate and the product details available in the complaint were incorrect.Attempts were made to obtain additional information about the correct product details but response received stating no further information is available regarding product details thus product tabs are updated as unknown.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.X-ray review: one anteroposterior (ap) x-ray, taken on an unknown date, was provided for analysis with (b)(4).The implant components appear adequately sized and positioned.However, a definite analysis cannot be made due to the suboptimal quality of the image and without mediolateral (ml) x-rays.Two suture anchors ¿ one in the distal femur, another in the proximal tibia - are visible, which suggest that the patient has had ligament reconstruction surgery.The patient left knee appears to be at a valgus angle.However, that cannot be confirmed without full leg x-rays.Email communications mention that: surgical reports and patient information are not available due to gdpr regulations; the surgical technique for the product was utilised; there were no contributing conditions related to the event; revised components are not available for return due to hosp policy during covid.The zimmer biomet product experience report (zper) further states that there are no historic clinical notes.The oldest version of instructions for use provided with cementless oxford devices mention: contraindications: insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device.Warnings: malalignment or soft tissue imbalance can place inordinate forces on the components which may cause excessive wear to the patellar or tibial bearing articulating surfaces.Revision surgery may be required to prevent component failure.The mhrs for the oxford partial knee anatomical bearing, femoral component and tibial tray have been requested but were not available at the timing of writing of this review because the part and lot numbers of the components are unknown.The cause of revision was progressive arthritis to the lateral compartment, as stated in the complaint description.It is possible that soft tissue imbalance and a valgus angle of the knee may have contributed to the disease progression.However, that cannot be confirmed without patient information (age, height, weight, and activity level), notes from primary and revision surgeries, post-primary and pre-revision ml and ap x-rays, and analysis of the revised components.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.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.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• Type of Device: UNKNOWN OXFORD CEMENTLESS TIBIAL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11003216
• MDR Text Key: 221280665
• Report Number: 3002806535-2020-00527
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

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
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/15/2021; 03/26/2021
• Supplement Dates FDA Received: 01/22/2021; 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention