MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-36; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)

Patient Problems Osteolysis (2377); No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the devices, x-rays, or other source documents for review.Where lot numbers were received for the device, the device history record were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available, that changes this assessment; an amended medical report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that the surgeon could not thread the locking cap onto the screw head on (b)(6) 2016.Patient presented osteolysis.Surgery was finalized with another device and it is unknown for how long was surgery extended.

Manufacturer Narrative

Investigation results were made available.Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: it was reported that the surgeon was not able to tighten the locking cap of the screw head.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 (b)(6) for in-depth analysis root cause analysis: root cause determination using dfmea: inability to place locking cap, liner, glenosphere due to surgeon fails to fully insert screws into bone => possible: as it is unknown if the screw was fully inserted to the bone.No information like surgical notes or x-rays were available.Therefore this point cannot be excluded.Components which not mate properly due to interaction of parts outside of design requirements and intent (i.E.Instruments and implants form connections which are not desired) => possible: as it is unknown if the locking cap was placed on the compatible screw.Conclusion summary: neither x-rays, operative notes, office visit notes, nor devices or photos of the products were received; therefore the condition of the components is unknown.In conclusion, due to significant lack of information, it is impossible to find a root cause of the event.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-36
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5705548
• MDR Text Key: 46784504
• Report Number: 0009613350-2016-00838
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.036
• Device Lot Number: 2799802
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 91