MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 11/10/2014

Event Type  Injury  

Manufacturer Narrative

Where lot numbers were received for the device, the device history record were reviewed and found to be conforming the device has not been received for investigation as the patient has not been revised.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¿s reference number of this file is (b)(4).Note: this is a split case with the zimmer inc.(b)(4), mfr#1822565-2016-00885.

Event Description

It is reported, that a patient was implanted with a anatomical shoulder reverse, screw system, 4.5-42 on (b)(6) 2013.It is also reported ,that the patient is experiencing drainage of fluid at the incision site.

Manufacturer Narrative

An evaluation of the provided information has been made available.Device history records: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description: it was reported that the patient received a right shoulder total arthroplasty on (b)(6) 2013.After implantation several drainages were performed.The latest drainage was performed on (b)(6) 2014.On (b)(6) 2016 a medical check-up confirmed a no wound healing.The product is still implanted.Review of received data: three post-operative undated x-rays were received showing a right tsa from different perspectives.No signs of loosening or osteolysis observed around the screws.One perspective suggested that the patient has a humeral ossification as it seems that the humeral bone shaft is slightly deformed.However, this does not correlated with the reported event.Implantation report dated (b)(6) 2013: a (b)(6) patient underwent a tsa to right shoulder due to rotator cuff tear arthroplasty with biceps tenosynovitis.The intervention was performed according indications.No conspicuous information found.According to the patient history, the patient underwent several drainage of hematoma occurred post operatively.The patient suffers from coronary artery disease and underwent to mitral valve replacement.Devices analysis: no device analysis could be performed as the product still implanted in the patient.Possible root causes: poor clinical outcome, insufficient function, insufficient rom, soft-tissue damage, loosening (due to higher joint loads) due to over-stuffing of joint due to incorrect selection of implants: it is possible that soft tissue damage occurred during implantation which led to a complicated clinical outcome and continuous drainage; soft tissue and nerve damage, loss of joint function, pain due to surgeon uses too long screws into bone: possible as just one post-operative x-ray received.Cannot be excluded.Loosening, potential for soft tissue damage due to instability, implant damage, luxation due to surgeon inserts and prepares glenoid with implant rotated by 180 degrees around medio-lateral axis: not possible as no signs of loosening observed.As the patient received artificial heart valves it is possible that is treated with anti coagulating medicaments.This may contributed to the difficulties in the healing of the wound.However, due to significant lack of information, it was impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause could not be determined.Zimmer (b)(4) consider this case as closed.Note: this is a split case with zimmer inc.(b)(4).Zimmer's reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42
• 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: 5583850
• MDR Text Key: 42852416
• Report Number: 0009613350-2016-00573
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 2697315
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• 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: 72 YR
• Patient Weight: 105