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); Failure of Implant (1924); 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, 50-21, r=27.6mm item#0104213505 lot#2867923 anatomical shoulder, glenoid, pegged, cemented, m item#0104214370 lot#2993482   multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00240, 0009613350-2023-00242, 0009613350-2023-00243 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 shoulder surgery.Post-operative grade iv glenoid radiolucency with osteolysis in zones 1-3, osteophytes, and grade iii heterotopic ossification were diagnosed approximately three (3) years after surgery.Revision surgery is planned.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a2, b4, b5, d4, d6, d9, d10, e1, g3, g6, h1, h2, h3, h6, h10.D10 ¿ anatomical shoulder, humeral stem, uncemented, 14, 100 mm item#01.04201.143 lot#3014292 anatomical shoulder domelock, humeral head, 50-21, r=27.6mm item#01.04213.505 lot#2867923 anatomical shoulder, glenoid, pegged, cemented, m item#01.04214.370 lot#2993482 unknown bone cement item#unknown lot#unknown.Initial bilateral anatomic total shoulder arthroplasties were performed at the three year follow up visit for the left side, grade iv glenoid radiolucency with osteolysis in zones 1-3, osteophytes, and grade iii heterotopic ossification were noted on x-ray.The patient also reported decreased strength, range of motion, and satisfaction with moderate-severe pain.Subsequently revised 3 years later.During the revision the glenosphere was loose, the stem was well intact and remained implanted.The glenoid, shell, liner were exchanged without complication.No product 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 the reported products were reviewed for compatibility with no issues noted.Review of complaint history for the stem, dome and liner identified additional similar complaints for the reported items and part and lot combinations.Complaints are monitored through monthly complaint review (reference wt-wi 423801) in order to identify potential adverse trends.Review of complaint history for the humeral head found no additional related issues for this item and the reported part and lot combination.Crf report as well as the surgical report for revision surgery were 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 left shoulder were provided and assessed by mri (hcp - radiologist) with the following assessment: 2020- normal alignment of the left glenohumeral arthroplasty 2022- there is early osteolysis along the glenoid implant and at the proximal humeral bone-metal interface 2023- there is marked progression of the proximal humeral osteolysis and 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.

• 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: 17037628
• MDR Text Key: 316294305
• Report Number: 0009613350-2023-00241
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• 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: 01.04227.005
• 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: 07/28/2023
• 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: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG