MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Therapy date : item#:42522401013; articular surface fixed bearing posterior stabilized (ps) right 13 mm height lot#:63133891.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Bilateral tka performed approximately one year ago.Patient experienced a fall and several weeks later developed right knee pain, swelling, and patella was found to be subluxing/dislocating.Patient underwent revision of right knee patella and poly liner.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.As it is unknown what caused the fall and patellar dislocation, a definitive root cause could not be determined with the information 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.

• Brand Name: ALL POLY PATELLA CEMENTED 38 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10478427
• MDR Text Key: 205290086
• Report Number: 0002648920-2020-00393
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024247659
• UDI-Public: (01)00889024247659
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000038
• Device Lot Number: 64422815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• 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
• Patient Weight: 116