MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TINBN FEMORAL COMPONENT; KNEE ARTHROPLASTY

Model Number N/A

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

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00303.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

Manufacturer Narrative

D3, g3, h2,h3 and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that no patient harm or injury was sustained as a result of this device related incident.Per correspondence, all parts of the drill were removed with a ¿pair of cockers¿ and the procedure was completed with an identical backup device within a 0-30-minute surgical extension.Reportedly, no further unplanned interventions were required or are anticipated.No further medical assessment is warranted based on the information provided.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.Damage from misuse or rough handling are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: product numbers of the components.Description: tinbn coated vanguard cr interlok femoral component 62.5mm right.Item: 183006tnbn.Description: polished finned 1 piece tibial tray 71mm coat.Tinbn.Item: 141253tnbn.Patella was not resurfaced, articular surface unknown.X-rays and surgical reports? requested.Whether revision surgery is planned? information requested.Patient details: name - not permitted.Date of birth ¿ (b)(6).Activity level - mostly inactive: very restricted to minimum activities of daily living weight ¿ unknown.Does the available information suggest the device/product caused or contributed to a death or serious injury? no, the surgeon chose not to report an adverse event so no serious injury took place.Was there medical intervention? no medical intervention was reported as no death or serious injury occurred.Preop, the patient presented with previous high valgus tibial repositioning osteotomy (hto), failed cruciate ligament arthroplasty and multiple knee arthroscopies.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Initial right tka on (b)(6) 2011.At ten year follow up, patient reported severe pain that interferes with activities of daily living.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.Mhr review could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 1 complaint reported with the item (initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : remains implanted.

• Brand Name: UNKNOWN TINBN FEMORAL COMPONENT
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12141664
• MDR Text Key: 260679443
• Report Number: 3002806535-2021-00302
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 183006TNBN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR