MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 14MM STD; PROSTHESIS, SHOULDER

Catalog Number 113654

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 03/10/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported patient underwent a left reverse total shoulder and experienced pain.Subsequently, the patient underwent an additional procedure approximately 11 months later due humeral shaft fracture.3 cerclage wires placed to repair the bone fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10 medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ct scan due to recent onset of pain revealed atrophy of supraspinatus and infraspinatus muscles.Cortical irregularity below lower tip of humeral component ¿ partially healed follow-up ct exam revealed midshaft humeral fracture, probably associated with implant placement, small crack in superior aspect at the base of the acromial spine which is consistent with the patient¿s history of an accident at physical therapy open reduction internal fixation of the left humerus periprosthetic fracture with cerclage wires review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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: COMP PRIMARY STEM 14MM STD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10254226
• MDR Text Key: 198303334
• Report Number: 0001825034-2020-02703
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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: 12/28/2019
• Device Catalogue Number: 113654
• Device Lot Number: 007880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 76