MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY; PROSTHESIS, EXTREMITIES

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s): unknown ulna; unknown articulation kit.Report source: foreign: event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00892.Device evaluated by mfr: product not returned.

Event Description

It was reported patient underwent a revision procedure approximately 14 months post-implantation due to loosening and pain.  attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

D11: item# 00840001407; lot# 63710294; ulnar component plasma sprayed size 4 75 mm length.Item# 00840009000; lot# 64093871; humeral screw kit 2 humeral screws.Item# 00840009500; lot# 64102160; articulation kit.  item# 66017787; lot# 89444785; palacos lv + g (1x40).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and x-rays which indicates premature loosening of humeral and ulnar left elbow prosthesis.Patient was presented with increasing load-dependent pain, complete loosening between the bone-cement interface as well as humeral and ulnar components.Visual examination of the returned product identified that the humeral and ulnar components contain large amounts of bone cement.The poly on the articulation kit components exhibit wear.Screw kit not returned.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00892, 0001822565-2020-02970.

Event Description

It was reported patient underwent a revision procedure approximately 14 months post-implantation due to suspected infection, loosening and pain.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9843510
• MDR Text Key: 191862717
• Report Number: 0001822565-2020-00891
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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: 00840004510
• Device Lot Number: 63710101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention