MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; SCREW, FIXATION

Model Number	115395
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fall (1848); Pain (1994)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: compr srs prox bdy - lg 42mm cat: 211218 lot: 186720.Compr srs mod stem - 10x75mm cat: 211232 lot: 088140.Comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 973590.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: 943880.Comp rvs tray co 44mm cat: 115370 lot: 045270.Arcom xl 44-36 std hmrl brng cat: xl-115363 lot: 056010.Comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 582270.Comp lk scr 3.5hex 4.75x20 st cat: 180551 lot: 582270.Comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 266170.Comp lk scr 3.5hex 4.75x25 st cat: 180552 lot: 850970.Report source: foreign: united kingdom.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00110, 0001825034-2023-00111, 0001825034-2023-00330, 0001825034-2023-00331, 0001825034-2023-00332, 0001825034-2023-00333, 0001825034-2023-00558, 0001825034-2023-00562, 0001825034-2023-00560, 0001825034-2023-00561.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 remains implanted.
Event or Problem Description
It was reported a patient had a conversion from a hemiarthroplasty to a reverse shoulder arthroplasty approximately three years and eight months ago.Subsequently, one year and seven months later, patient reports unusual pain following a fall onto outstretched hands.The patient underwent a course of physical therapy and takes otc medications as needed for pain.Approximately two months ago, radiographic imaging displayed stress shielding in lateral cortex and the patient is experiencing some difficulty performing daily activities.No plan for revision has been reported and the patient has remained extremely satisfied throughout the study.Attempts have been made and no further information has been provided.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: on (b)(6) 2020; ae; joint assist (14 pgs).Unusual pain after patient fell on outstretched hands; ct- negative findings; continuing with conservative treatment on (b)(6) 2022; 3 year follow-up; joint assist (14 pgs).Notes severe difficulty with ability to do household chores, use a knife to cut food, and carry a shopping bag; x-rays ap/lat ¿ stress shielding noted in lateral cortex; extremely satisfied on (b)(6) 2023; re: (b)(4) additional information 2.Msg clinical project lead reports patient currently had a course of physical therapy and takes over the counter analgesics as needed.Pain started after the fall radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment is anatomic on all images.Bone quality appears mildly osteopenic.There is interval development of proximal humeral stress shielding.Alignment is anatomic and unchanged from post-operative imaging through on (b)(6) 2022 but with interval development of proximal humeral stress shielding.There is no evidence of loosening.There is no malalignment.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 RVS CNTRL 6.5X25MM ST/RST
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16552678
• Report Number: 0001825034-2023-00543
• Device Sequence Number: 19575657
• Product Code: KWS
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074(17)280928(10)722960
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132239
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: 115395
• Device Catalogue Number: 115395
• Device Lot Number: 722960
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 115 KG