MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS IC SEG - 60MM; SHOULDER, PROSTHESIS

Catalog Number 211225

Device Problem Migration (4003)

Patient Problems Pain (1994); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: compr srs prox bdy cat: 211218 lot: unk; compr srs mod rgx aug cat: 211229 lot: unk; compr srs mod stem cat: 211259 lot: unk.Report source: foreign: (b)(6).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 report will be submitted.Product not returned.

Event Description

It has been reported that a patient underwent an initial left shoulder hemiarthroplasty performed.At the one year follow up visit, the patient reported severe pain, increased limitation to adls, and very low satisfaction level.Upon xray review, it was noted that the prosthesis had migrated due to rotator cuff insufficiency.No intervention has been reported to date.

Event Description

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

Manufacturer Narrative

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

This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.The event will be reported under medwatch #: 0001825034-2020-03218.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

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

• Brand Name: COMPR SRS IC SEG - 60MM
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9969719
• MDR Text Key: 191835786
• Report Number: 0001825034-2020-01671
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K173411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79