MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X35MM ST/RST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115397
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 or Problem Description
It was reported a patient underwent a left shoulder arthroplasty on an unknown date.Subsequently, had an incident where she put her arm in a reaching back position and felt the implant give.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported a patient underwent a left shoulder arthroplasty one (1) month ago.Subsequently, the patient had an incident where she put her arm in a reaching back position and felt the implant give.It was later confirmed a screw fractured.Surgeon plans to revise but surgery is not scheduled yet.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D2: device product code ¿ phx.D4: product id for five screws were provided; however, it is unknown which singular screw of the five had fractured.The product information for the remaining four screws are as follows: item #180555; lot #568490.Udi: (b)(4).Expiration date: dec 7, 2030.Item #180554; lot #182010.Udi: (b)(4).Expiration date: oct 23, 2030.Item #180554; lot #017910.Udi: (b)(4).Expiration date: feb 2, 2031.Item #180553; lot #274460.Udi: (b)(4).Expiration date: mar 3, 2031.D10: item #110019066; lot #196610.Item #110027734; lot #196580.Item #110031378; lot #196600.Item #00801102001; lot #63504694.Item #110034355; lot #936aaa2503.Item #110034355; lot #924aaa2503.Item #115310; lot #183440.Item #00435001313; lot #63020932.Item #00434903600; lot #64687459.H4: manufacturer date: item #180555; lot #568490 - manufacturing date: dec 7, 2020.Item #180554; lot #182010 - manufacturing date: oct 23, 2020.Item #180554; lot #017910 - manufacturing date: feb 2, 2021.Item #180553; lot #274460 - manufacturing date: mar 3, 2021.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a4; b4; b5; g3; g6; h1; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a fractured screw that appears to be at the glenoid implant of a reverse-type shoulder arthroplasty.Implant fit and alignment cannot be determined on this single very limited image.Bone quality cannot be determined on this image.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 which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP RVS CNTRL 6.5X35MM ST/RST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14218517
• Report Number: 0001825034-2022-00888
• Device Sequence Number: 4194656
• Product Code: KWS
• UDI-Device Identifier: 00880304677098
• UDI-Public: (01)00880304677098(17)310202(10)956940
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

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 Catalogue Number: 115397
• Device Lot Number: 956940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/12/2022; 06/08/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female