MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 3; PROSTHESIS, KNEE

Model Number N/A

Device Problems Failure to Osseointegrate (1863); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00596203212 - articular surface use with lps/lps-flex 51 or 52 suffix femorals size ef 12 mm height - 61512131.Unknown - unknown palacos cement - unknown.Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent an initial tka.Subsequently, the patient was revised approximately 10 years later as the stemmed tibia de-bonded from the cement.There was no surgical delay.The surgical technique was utilized.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.Visual examination of the returned product/provided pictures identified signs of repeated use (nicked, gouged, micro motion) and some of the bone cement remains.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision of tibial component.Inspection of femoral component showed this to remain quite stable.No complications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit appears normal.There is eccentric positioning of the tibial stem, described on the review assessment form.Bone quality appears normal.No confirmed signs of loosening, although there is a nonspecific subtle periprosthetic lucency described on the review assessment form.Eccentric positioning of the tibial stem within the proximal tibia could be related to surgical technique.If developing over time, then can be a sign of loosening.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT SIZE 3
• 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: 12083238
• MDR Text Key: 258885110
• Report Number: 0002648920-2021-00169
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K933785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 00598003701
• Device Lot Number: 61823347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 65