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

Catalog Number 00430204627

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the patient had post operative pain in conjunction with pain and alleges developing crps and sjorgens disease within three weeks post primary left shoulder in 2016.No further information is available.

Event Description

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

Manufacturer Narrative

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.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 was reported that patient underwent left shoulder arthroplasty (b)(6) 2017 and subsequently is experiencing pain and alleges developing crps and sjorgens disease within three weeks of the procedure.The patient has not been revised and is requesting material composition of the implanted devices.No further information is available at the time of this reporting.

Manufacturer Narrative

(b)(4).Concomitant medical products: primary di 00-4302-046-27 lot 62433463 bf offset hum head 27mm x 46mm 00889024265721,  00-4302-040-46 lot 63344409 bf 40mm pegged glenoid w/46mm 00889024265646 , 00-4342-110-13 lot 62867558 tm humeral stem 42 deg 00889024268630 .Multiple mdr's were filed for this event.Please see 0001822565 - 2019 - 01255, 0001822565 - 2019 - 02821, 0001822565 - 2019 - 02823.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned.Medical record were reviewed but was unable to confirm the report.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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: OFFSET MODULAR HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8451054
• MDR Text Key: 139802357
• Report Number: 0001822565-2019-01255
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 00430204627
• Device Lot Number: 62433463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 04/02/2019; 06/25/2019; 09/06/2019
• Supplement Dates FDA Received: 04/04/2019; 07/08/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR