MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER

Model Number 113952

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: (b)(6).Concomitant products: cat: 0104211093 lot: 2967376 anatomical shoulderâ?¢, humeral stem, cemented, 㸠9, 100 mm.Cat: 0104212465 lot: 2885133 anatomical shoulderâ¿¢ domelockâ®, humeral head, 㸠46- 16, r=26.1mm.Cat: 0104227005 lot: 2853488 anatomical shoulderâ?¢ domelock â®, dome, centric.Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 a left shoulder arthroplasty.Subsequently, the patient suffers from pain and underwent arthroscopic arthrolysis surgery and the event is defined as resolved.No additional patient consequences are reported at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the available records identified the following: no revision took place.Tsp glenoid intact without wear and is stable with intact labrum and cuff.Subacromial evaluation notes impingement and bursectomy.As no device has been removed, symptoms have resolved after this intervention, this is likely a soft tissue impingement.Device history record (dhr) was reviewed for deviations and/ or anomalies with the following anomalies/ deviations identified: one piece being out of spec and one piece having inclusions.Those 2 parts were scrapped as common cause scrap.Root cause was unable to 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: SM HYBRID GLENOID BASE 4MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11841878
• MDR Text Key: 251352215
• Report Number: 0001825034-2021-01508
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)240811(10)553070
• Combination Product (y/n): N
• PMA/PMN Number: K060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 113952
• Device Catalogue Number: 113952
• Device Lot Number: 553070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 60