MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.X-rays and surgical report of implantation were received and they will be reviewed as part of ongoing investigation.As soon as an investigation result will be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted an anatomical shoulder reverse, screw system, 4.5-30 on the right side on (b)(6) 2015.The patient was revised on (b)(6) 2016 due to loosening of the base plate and infection.

Manufacturer Narrative

The device was not returned for investigation, it is retained by the patient.No trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description (event details, per) - a revision surgery was performed on (b)(6) 2016 due to loosening of the baseplate.An infection was also found during the revision surgery.The loosening of the baseplate is handled in warsaw complaint (b)(4).The infection will be handled in this complaint.Review of received data - x-rays, intraoperative screenings & pictures: a x-ray for this case was provided.The x-ray picture is undated.There are no screws visible on the x-ray.The loosening can be confirmed.- surgical notes & patient history: the surgical report of implantation dated (b)(6) 2015 was received.Diagnosis: secondary arthrosis.Lesions of the rotator cuff.Indication: pain and dysfunctional rotator cuff deficiency.Report: during the surgery an omarthrosis was found and arthrosis on the glenoid.The report also describes that the patient has significant osteoporosis.Finally, free articulation without conspicuous notching with good tension was achieved.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.The device is retained by the patient.Review of product documentation - ifu: the ifu for anatomical shoulder¿ system states that "surveillance for new or recurrent infections should be continued as long as the device is in place." the gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lots has been reviewed and was found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for the lots.It is highly unlikely that a disadvantageous product design favored or contributed to the infection.The ifu for anatomical shoulder¿ system states that "surveillance for new or recurrent infections should be continued as long as the device is in place." however, there is no evidence of infection.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported, that the patient was implanted an anatomical shoulder¿ system on (b)(6) 2015 on the right side and a revision surgery was performed on (b)(6) 2016 due to loosening and infection.Note: - the loosening of the baseplate is handled in warsaw complaint (b)(4).- the infection will be handled in this complaint (b)(4).

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30
• 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: 6263648
• MDR Text Key: 65265033
• Report Number: 0009613350-2017-00075
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.030
• Device Lot Number: 2794522
• Other Device ID Number: 00889024286009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2015
• 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): Hospitalization; Required Intervention
• Patient Weight: 53