MAUDE Adverse Event Report: ZIMMER, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH; PROSTHESIS ELBOW

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Information (3190)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - humeral screw kit 2 humeral screws, catalog # 00840009000, lot # 63139663.This investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient's humeral components shows signs of loosening.An aspiration was performed.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Concomitant medical product: nexel total elbow ulnar component, catalog#: 00840002407, lot#: 63040257.Articulation kit, catalog#: 00840009400, lot#: 63085698.Humeral screw kit, catalog#: 00840009000, lot#: 63139663.Cemex bone cement, catalog#: ni, lot#: ni.Reported event was confirmed by review of medical records provided.No x-rays were provided.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Event Description

It is reported that patient experienced pain, instability, severe right humeral component loosening and subsidence approximately 14 months post-implantation.Patient also exhibited ulnar and humeral osteolysis.Patient was treated by aspiration of approximately 15 cc from the operative elbow.Outcome is pending.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH
• Type of Device: PROSTHESIS ELBOW
• 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: 6776349
• MDR Text Key: 82117255
• Report Number: 0001822565-2017-05231
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• 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: 00840004410
• Device Lot Number: 63050690
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 88