MAUDE Adverse Event Report: BIOMET UK LTD. RHK 10X80 CEMENTED STEM; KNEE PROSTHESIS

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: offset tib tray 2.5mm adaptor, catalog# 141490 lot# 207560, vanguard (tm) ssk femoral catalog # 183300 lot # 460060, agc modular post screw catalog # 153103 lot # 570770, rhk cemented stem catalog # 159405 lot unknown, biomet offset tibial tray 67mm catalog # 141482 lot # 985260 , vngd sskpsc tib brg s 16x63/67 catalog # 183826 lot # 467180 , series a pat std 31 3 peg catalog # 184764 lot 494690.Customer has indicated that the product will not be returned because it was discarded by hospital.The investigation is in process.Multiple mdr reports were filled for this event: 0001825034-2019-01022, 0001825034-2018-05848, 0001825034-2019-01017, 3002806535-2019-00359.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It has been reported by the hospital that a patient underwent an initial knee replacement surgery on an unknown date.Subsequently, a revision procedure was performed due to tibial component loosening.During the revision the surgeon experienced difficulties with extraction of distal tibial component and femoral component, which were left in situ.The products were removed during further revision.

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.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 Description

It has been reported by the hospital that a patient underwent an initial knee replacement surgery on an unknown date.Subsequently, a revision procedure was performed due to tibial component loosening.During the revision the surgeon experienced difficulties with extraction of distal tibial component and femoral component, which were left in situ.The products were removed during further revision.

• Brand Name: RHK 10X80 CEMENTED STEM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8494678
• MDR Text Key: 141304309
• Report Number: 3002806535-2019-00358
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159403
• Device Lot Number: 1634006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention