MAUDE Adverse Event Report: ZIMMER INC ZIMMER UNIVERSAL ARTICULAR SURFACE; KNEE PROSTHESIS

Catalog Number 00584202209

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Depression (2361); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a.(b)(4).No devices or photos were received; therefore the condition of the components is unknown.The device history records could not be reviewed as the part and lot number is unknown.This device is used for treatment.The video clip provided with the complaint had a clicking noise that could be heard when the patient tried to move his leg to and fro.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported that the patient was revised due to pain, lack of motion, and depression.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay additional/corrected information, which was unknown at the time of the initial medwatch.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 that the patient was revised two months post-implantation.No further information has been made available.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.Medical products- zimmer universal fixed tibial component, catalog # 00584200202, lot # 62850859.Zimmer universal femoral component, catalog # 00584201302, lot # 62543939.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-00945; 0001822565 -2018 -00946.

Event Description

It was reported that the patient had initial right knee arthroplasty.The patient was experiencing pain, swelling, limited range of motion, balance issues with restrictions on activities post implantation.Additionally, it was also reported that after surgery the polyethylene spacer dislodged.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Root cause 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: ZIMMER UNIVERSAL ARTICULAR SURFACE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5367314
• MDR Text Key: 35979428
• Report Number: 1822565-2016-00090
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 00584202209
• Device Lot Number: 62849181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 57