MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-48; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a anatomical shoulder reverse, screw system, a 4.5-18 on an unknown side on (b)(6) 2016 and the patient underwent revision surgery on (b)(6) 2017 due to baseplate to glenoid interface failed.*note: this is a split case with zimmer inc., (b)(4) reference number (b)(4).

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: revision due to loosening.Review of event description: it was reported that a patient was revised 1 year post implantation due to failure of the baseplate to glenoid interface.The glenoid component became loose and needed revision.This complaint is a split case with zimmer inc., warsaw (b)(4).(mfr 0001822565-2017-08128) review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the information received the device was discarded at the hospital as biohazard.Root cause analysis: root cause determination using dfmea: - insufficient primary stability of glenoid baseplate leading to loosening, pain, loss of function due to fixation of screws within bone is insufficient for intended use due to design => not possible: a systematic issue with design would have been detected as part of the issue evaluation assessment.- insufficient primary stability of glenoid baseplate leading to loosening, pain, loss of function due to surgeon uses too short screws into bone => possible: as with the information provided, it cannot be verified i f the choosen screws were in appropriate lenght.- disassociation, loss of function, pain due to locking strength of screw cap to baseplate, locking the screw position, is insufficient => possible: as with the information provided, it is unknown if the surgeon followed the surgical technique and/or if the surgeon is familiar with the suggested surgical technique.- insufficient primary stability of glenoid baseplate leading to loosening, pain, loss of function due to surgeon over-torques screws into bone => possible: as with the information provided, it is unknown if the surgeon followed the surgical technique and/or if the surgeon is familiar with the suggested surgical technique.Conclusion summary: neither x-rays or operative note were received; therefore the condition of the component is unknown.The device was was not received for investigation.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The conducted root cause analysis did not come up with a specific root cause.A potential root cause might be that the surgeon did not follow the surgical procedure since a surgical report is not at hand and /or an other potential root cause might be wrong patient behaviour since adherence to rehabilitation protocol is unknown.However, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted an anatomical shoulder reverse, screw system, and underwent a revision surgery after one year due to baseplate to glenoid interface failed.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-48
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7070135
• MDR Text Key: 93292440
• Report Number: 0009613350-2017-01694
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.048
• Device Lot Number: 2853359
• Other Device ID Number: 00889024483064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR