MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CEMENT R 1X40 US; ORTHOPAEDIC CEMENT, MEDICATED

Catalog Number 110035368

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).List of associated devices: natural tibia cemented 5 degree stemmed left size e, reference 42532007101, batch 64794770; reference :150464 oss 3cm diaphysel segment lot : 119830; reference :150493 oss reinforced yoke batch : 293590; reference :150477 oss poly femoral bushings 2pk batch : 869290; reference :130615 intramedullary plug xl batch : 372180; reference :150480 oss axle batch : 171210; reference :150355 oss 7cm segmental femoral lt batch : 188880; reference :150388 oss porous im stem 17.5 x 90 batch : 427060; reference :150476 oss poly tibial bushing batch : 783180; reference :150411 oss tibial poly bearing 14mm batch : 274210; reference :130613 intramedullary plug lge batch : 003670; reference :150413 oss tibial poly bearing 18mm batch : 948210; reference :150355 oss 7cm segmental femoral lt batch : 188940; reference :150493 oss reinforced yoke batch : 898000; reference :150477 oss poly femoral bushings 2pk batch : 533050; reference :150480 oss axle batch : 826040; reference :150482 oss 4cm diaphyseal segment batch : 289650; reference :150366 oss cemented im stem 12x150 batch : 994210; reference :150478 oss poly lock pin batch : 207110.Report source, foreign - health professional - event occurred in united states.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported patient underwent a left knee arthroplasty on (b)(6) 2020.Subsequently, the patient was revised on (b)(6) 2021, due to a looseporous stem and femoral component.Dr.(b)(6) revised with an oos femur and a cemented stem.

Manufacturer Narrative

Cmp-(b)(4).This follow-up is to relay additional information.The following sections were updated : b4, g3, g6, h2, h6, h10 the product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.No other complaint on medical: revision due to loosening was recorded on the batch since ever, and 5 other complaints on medical: revision due to loosening was recorded on the reference from apr 1, 2018 to sep 23, 2021.According to available data, root cause of the event 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.

Event Description

It was reported patient underwent a left knee arthroplasty on (b)(6) 2020.Subsequently, the patient was revised on (b)(6) 2021 , due to a loose porous stem and femoral component.Dr.(b)(6) revised with an oos femur and a cemented stem.

• Brand Name: BIOMET BONE CEMENT R 1X40 US
• Type of Device: ORTHOPAEDIC CEMENT, MEDICATED
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11805523
• MDR Text Key: 249973230
• Report Number: 3006946279-2021-00082
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: 0887868214578
• Combination Product (y/n): N
• PMA/PMN Number: K172408
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 110035368
• Device Lot Number: 927BAA2502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention