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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); No Information (3190)

Event Date 12/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Implant date - (b)(6) 2009.Reported event was unable to be confirmed as lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is 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.Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-01899, 01495.

Event Description

It was reported that a patient underwent an extremity procedure.The patient was revised due to migration and subluxation approximately 8 years post-implantation.Patient reportedly received a recall letter for this product a number of years ago.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Implant date is reported to be some time in 2008.Concomitant medical product: modular humeral stem 13 mm diameter 130 mm length, catalog #: 00430001313, lot#: 60999154.

Event Description

It was reported patient underwent an initial total shoulder arthroplasty.Subsequently, patient was revised approximately eight years post-operatively due to the humeral head disassociating from the humeral stem, pain, and the implant "catching".No additional patient consequences were reported.

• Brand Name: OFFSET MODULAR HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6437320
• MDR Text Key: 70969319
• Report Number: 0001822565-2017-01899
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00430205219
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 67