MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: patell item # unknown lot 3 unknown, art surface item # 42522400711 lot # 63119959, femur item # 42500606402 lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will no permit.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee procedure; subsequently 30 months later the patient was revised due to loosening.Presumed loosening of tibial component.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records for the initial surgery identified no intra op complications.Op notes for the revision surgery were not provided.Per persona the personalized knee system package insert, loosening is a known potential adverse effect of this procedure.However, a definitive root cause cannot 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

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

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F
• 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: 8715629
• MDR Text Key: 148522297
• Report Number: 0002648920-2019-00430
• Device Sequence Number: 1
• Product Code: MBH
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 42532007502
• Device Lot Number: 63133996
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 84