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

Catalog Number 01.04223.030

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents 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.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted an inverse/reverse screw system, 4.5-30 on (b)(6) 2015.The patient was revised on (b)(6) 2015 due to infection.

Manufacturer Narrative

Dhr review: dhr records were reviewed and found to be conforming.Trend analysis: no trend identified.Compatibility check: the compatibility check was performed and showed that the product combination was approved by zimmer (b)(4).Review of incoming information: it was reported that the patient received the inverse/reverse screw system with compatible products from zimmer inc., (b)(4) (reported in (b)(4)) in (b)(6) 2015 and was revised in (b)(6) 2015 (7 months later) due to infection.One x-ray, dated (b)(6) 2015, was returned for review.It was unknown if it was taken previous or after revision surgery.The proximal cortical bone of the humerus showed a spongy-like structure.It was unknown if it was due to infection or other factors occured in patient history.No other documents were provided for investigation.Devices analysis: devices analysis could not be performed as no product was available for investigation review of internal documents: review of irradiation certificate and sterilization master file: all devices were sterilized according to the defined specifications.The sterilization process has been validated by zimmer (b)(4).Root cause analysis: the product related to the reported event was not available for investigation.In addition, no other relevant report (e.G.Surgical reports, blood tests, etc.) was provided.The surgeon complained that the patient underwent revision after 7 months implantation due to infection.Gamma sterilization specification certify the suitability of sterilization.Therefore it could be excluded that the device caused or contributed to the infection.However, all possible causes related to the issues reported are listed in dfmea.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.(b)(4).

• Brand Name: INVERSE/REVERSE SCREW SYSTEM, 4.5-30
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5030823
• MDR Text Key: 24045289
• Report Number: 9613350-2015-01029
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 01.04223.030
• Device Lot Number: 2715871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR