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

Model Number	113952
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No additional event information is available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11841878
• Report Number: 0001825034-2021-01508
• Device Sequence Number: 3223951
• Product Code: KWS
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)240811(10)553070
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K060694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2024
• 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 Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 60