MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SEE H10 NARRATIVE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Swelling (2091)

Event Date 06/23/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Brand name: tibial component pegged precoat for cemented use only size 3.Concomitant medical products: nexgen pre-coat cr-flx gender femoral component, catalog #: 00575001401, lot #: 61886308.Prolong cr-flex nexgen articular surface, catalog #: 00595203010, lot #: 62638441.All poly patella standard size 29 mm diameter 8.0 mm thickness for cemented use only, catalog #: 00597206629, lot #: 62257591.Device evaluated by mfr: customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00139, 0001822565-2019-01764, 0001822565 -2019-01880.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 patient underwent left total knee arthroplasty.Subsequently, three weeks post implantation, the patient underwent an aspiration of 15ml of serosanguineous fluid from the joint due to moderate swelling.

Manufacturer Narrative

Reported event was confirmed by review of medical records.Medical records note that the patient was treated for swelling 3 weeks post implantation.Device history record (dhr) was reviewed and no discrepancies were found.Per package insert: swelling is a known adverse effect of this system.However, a definitive root cause cannot 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.

Event Description

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

• Brand Name: SEE H10 NARRATIVE
• 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: 8587204
• MDR Text Key: 144296096
• Report Number: 0002648920-2019-00317
• 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: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00597003501
• Device Lot Number: 62580095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90