MAUDE Adverse Event Report: BIOMET SPAIN, S.L. NON-POROUS PERF TIB TRAY-LGE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Osteolysis (2377)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated medical products: ref.(b)(4); lot 151670; description ps constrained insert lge 22mm w/screw.Ref.(b)(4); lot 2007010785; description anatomical tibial stem 14x120x5mm.Ref.(b)(4); lot 2007030389; description femoral stem 16x150mm w/screw.Ref.(b)(4); lot 05037715; description ps femoral component closed box med left 70 mm cemented.Reporter: (b)(6).Foreign report source: (b)(6).This product is manufactured by (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k143192.Multiple mdr reports were filed for this event, please see associated reports: 0009610576 - 2020 - 00008 and 0009610576 - 2020 - 00009.

Event Description

It was reported by the (b)(6) agency of medicines and medical devices patient underwent total knee arthroplasty on an unknown date in 2008.Subsequently, patient underwent a revision (b)(6) 2020 due to instability of total revision knee prosthesis implemented in 2008 due to the breaking of the central stabilization post of the same, with loosening of the female stem screw, presence of multiple osteolysis, polyesile metal disposal.The central post was found in the hollow popliteo.Reconstruction is needed with constrained implant and increases of trabecular metal given the loss of substance and the affection of the lig.Sides.

Event Description

Revision due to instability, loosening of female screw, osteolysis, polyesile metal disposal.

Manufacturer Narrative

(b)(4).D11: associated medical products.Ref.178892; lot 0000151670; description ps constrained insert lge 22mm w/screw.Additional information regarding the involved lots detected during the documental investigation.

• Brand Name: NON-POROUS PERF TIB TRAY-LGE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• MDR Report Key: 10402752
• MDR Text Key: 209435103
• Report Number: 0009610576-2020-00007
• Device Sequence Number: 1
• Product Code: KRR
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 177284
• Device Lot Number: 2007050790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization