MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 10X75MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED

Catalog Number 211232

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

Patient Problems Erosion (1750); Fall (1848); Pain (1994)

Event Date 12/04/2020

Event Type  Injury  

Event Description

It was reported a patient had a conversion from a hemiarthroplasty to a reverse shoulder arthroplasty approximately three (3) years and eight (8) months ago.Subsequently, one (1) year and seven (7) 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 (2) 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.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00110.Concomitant medical products: item# 211218; lot# 186720.Full establishment name - (b)(6) hospital.Event occurred in the united kingdom.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 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.D10: compr srs prox bdy - lg 42mm cat: 211218 lot: 186720, comp rvrs shldr glnsp std 36mm cat: 115310 lot: 943880, comp rvrs 25mm bsplt ha+adptr cat: 010000589 lot: 973590, comp rvs tray co 44mm cat: 115370 lot: 045270, arcom xl 44-36 std hmrl brng cat: xl-115363 lot: 056010, comp rvs cntrl 6.5x25mm st/rst cat: 115395 lot: 722860, 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: 860970.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00110, 0001825034-2023-00330, 0001825034-2023-00331, 0001825034-2023-00332, 0001825034-2023-00333.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Comp rvs cntrl 6.5x25mm st/rst cat: 115395, lot: 722960.Comp lk scr 3.5hex 4.75x25 st cat: 180552, lot: 850970.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00543, 0001825034-2023-00558, 0001825034-2023-00562, 0001825034-2023-00560, 0001825034-2023-00561.H6: proposed code: mechanical (g04)- stem.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: COMPR SRS MOD STEM - 10X75MM
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED
• 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: 16213798
• MDR Text Key: 307770486
• Report Number: 0001825034-2023-00111
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 211232
• Device Lot Number: 088140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.; SEE NARRATIVE IN H10.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 115 KG