MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X20 ST; SHOULDER PROSTHESIS/EXTREMITIES

Model Number N/A

Device Problem Migration (4003)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02715, 0001825034-2021-02716, 0001825034-2021-02717.Medical products: item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 702590, item#: 115397, comp rvs cntrl 6.5x35mm st/rst; lot#: 898410, item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 740930, item#: 115313, comp rvsr shldr glnsp +3 36mm; lot#: 536220, item#: 00434903600, poly liner plus 0 mm offset 36 mm diameter; lot#: 64410128, item#: 00434903909, humeral stem spacer size 9; lot#: 64227036, item#: 405883, comp rvs 3.2mm drl; lot#: 555880, item#: 405889, comp rvs 2.7mm dia drl; lot#: 518650.Customer has indicated that the product will not be returned to zimmer biomet for investigation, request was made for return of product but hospital would not return product.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 had an initial right shoulder arthroplasty on an unknown date due to bone fracture.The patient was revised approximately one (1) year and three (3) months ago due to rotator cuff pathology.Subsequently, approximately more than a one (1) year later the implants migrated due to the patient¿s bone being poor and is being considered for another revision on an unknown date.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02715-1.0001825034-2021-02716-1.0001825034-2021-02717-1.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 not provided.A definitive root cause cannot be determined.A possible contributing condition to the event was the patient's poor bone quality as noted by the sales rep, however, this was unable to be confirmed with medical records.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

It was reported a patient has been indicated for shoulder arthroplasty revision due to loss of fixation of the screws of the glenoid component.This was attributed to poor bone quality and high activity of the patient.No revision or additional patient consequence has been reported.

• Brand Name: COMP LK SCR 3.5HEX 4.75X20 ST
• Type of Device: SHOULDER PROSTHESIS/EXTREMITIES
• 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: 12540453
• MDR Text Key: 273581212
• Report Number: 0001825034-2021-02718
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180551
• Device Lot Number: 791500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female