MAUDE Adverse Event Report: ZIMMER, INC. TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104)

Event Date 02/01/2016

Event Type  Injury  

Event Description

It is reported that the patient is experiencing pain after a knee arthroplasty.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Brand name - tibial component precoat right medial/left lateral size 3.Common device name - hsx.Model #/lot # ¿ catalog 00584200302 lot 62802366, exp aug 31, 2024.Implant date ¿ (b)(6) 2014.Concomitant medical products ¿ (b)(6) 2016.Date received by mfr.- jun 27, 2017.Pma - k033363.Device manufacture date - sep 15, 2014.(b)(4).Concomitant medical products- femoral component catalog 00584201402 lot 62761646; articular surface size 3 9 mm height catalog 00584209309 lot 62482647.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed through receipt of mri report.Product was not returned for evaluation.Dhr was reviewed and no discrepancies were found.Review of the 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.A definitive root cause cannot 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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Corrected: date received by mfr - initial ( jan.3, 2017).

• Brand Name: TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6300183
• MDR Text Key: 66467551
• Report Number: 0001822565-2017-00545
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• 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: 00584200302
• Device Lot Number: 62802366
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: Yes
• 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: 68 YR