MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).An additional report was submitted for this event: mfr# 0001822565-2018-00270.Concomitant medical products: trabecular metal reverse humeral stem pnunk lnunk.Consumer report source-legal counsel.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent right shoulder surgery.Subsequently, the patient underwent a revision procedure four years later due to patient allegations of loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: unknown trabecular metal stem.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history review was unable to be performed, as the part number and lot number are unknown.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.

Manufacturer Narrative

Root cause remains undetermined.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 that the patient underwent right shoulder surgery.Subsequently, the patient underwent a revision procedure four years later due to patient allegations of loosening.Patient also experienced pain and limited range of motion.No further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: tm stem 1 48 deg 18 mm x 130 mm cat#: 00434811813, lot#: 61905055.Trabecular metalâ¿¢ glenoid component 52 mm articular surface use with blue instruments & blue humeral head cat#: 00432605200, lot#:62338786.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Compatibility check noted no issues.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: MODULAR HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7187523
• MDR Text Key: 97269484
• Report Number: 0001822565-2018-00107
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00430005221
• Device Lot Number: 62433484
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• 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: 65 YR