MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE UNCEMENTED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 00434903811

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Localized Skin Lesion (4542); Skin Infection (4544)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device product code - phx.Concomitant products: item# 00434904011; lot# 64032723.Item# 00434904000; lot# 64560444.Item# 0104223036; lot# 3043248.Item# 0104223042; lot# 3021386.Report source: foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was sent for pathology testing.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

It was reported that the patient was revised approximately one (1) year and one (1) month post-implantation due to screw fracture and loosening of baseplate.Additionally patient had an infected skin lesion treated three (3) weeks prior to revision.Surgeon mentioned that infected skin lesion and the fact the patient is a farmer with high physical demands may have contributed to the baseplate loosening.Attempts have been made and no further information has been provided.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The sterile cert within the device history record was reviewed and found that the devices were sterilized per specification.A definitive root cause cannot be determined for loosening.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the histopathology reported mild pale histiocytic infiltrate, suggestive of prosthesis wear; degenerative changes; no evidence of infection.The root cause of the previous investigation does not change.If any further information 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: BASE PLATE UNCEMENTED
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 13693620
• MDR Text Key: 286837421
• Report Number: 0001822565-2022-00687
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00889024269101
• UDI-Public: (01)00889024269101(17)300430(10)64556002
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130661
• 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,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434903811
• Device Lot Number: 64556002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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 NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 90 KG