MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2 ¿ foreign ¿ switzerland.D10 ¿ anatomical shoulder, humeral stem, uncemented,14, 100 mm item#0104201143, lot#3014292.Anatomical shoulder domelock, humeral head, 50-18, r=27.6mm item#0104212505, lot#2895509.Anatomical shoulder, glenoid, pegged, cemented, m item#0104214370, lot#2993482.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00230, 0009613350-2023-00231, 0009613350-2023-00233.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent initial bilateral anatomic total shoulder arthroplasties.Post-operative grade iv glenoid radiolucency with osteolysis in zones 1-3, osteophytes, and grade iii heterotopic ossification were diagnosed approximately two (2) years after surgery and decreased strength, range of motion, and satisfaction with mild-moderate pain were reported approximately three (3) years from initial shoulder arthroplasty.Revision surgery is planned.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Initial bilateral anatomic total shoulder arthroplasties were performed.At the two year follow up visit for the right side, grade iv glenoid radiolucency with osteolysis in zones 1-3, osteophytes, and grade iii heterotopic ossification were noted on x-ray.By the three year follow up, the patient reported decreased strength, range of motion, and satisfaction with mild-moderate pain.A revision from an anatomic to reverse is planned.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Crf report was received and reviewed by the nurse review group (hcp), for which a timeline report was created.The following findings were noted during initial implantation: sclerotic bone, large osteophytes, rotator cuff intact, subscap and capsule releases, no intraop complications noted, pressfit stem, cemented glenoid, discharged postop day 5, pt started, mobilized within 24 hours of surgery.Six radiographic images of the right shoulder were provided and assessed by mri (hcp - radiologist) with the following assessment: 2020: normal alignment of the right glenohumeral arthroplasty.2022: there is early osteolysis along the glenoid implant and humeral bone-metal interface.2023: there is marked progression of the proximal humeral osteolysis with more mild progression of the glenoid osteolysis.The following impressions were additionally provided: initial normal appearance of bilateral shoulder arthroplasties with progressive development of advanced bilateral implant osteolysis as noted, greater at the humeral implants.While there is no implant displacement to confirm loosening, the degree of bilateral humeral osteolysis would suggest early loosening.Overall alignment is maintained.Bone quality appears mildly osteopenic.Based on the given information and the results of the investigation, a definitive root cause cannot be determined.If any further information is found 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 Description

No further event information available at the time of this report.

• Brand Name: ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17018235
• MDR Text Key: 316097854
• Report Number: 0009613350-2023-00232
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00889024485006
• UDI-Public: (01)00889024485006(17)240331(10)2992775
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K193099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 0104227005
• Device Lot Number: 2992775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEEH10NARRATIVE.
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG