MAUDE Adverse Event Report: ZIMMER GMBH ULNA GSB-III; GSB ELBOW

Catalog Number UNKNOWN

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

As the case at hand was taken from a journal article it is not suspected that the device or additional information is being submitted for review.A technical investigation was not possible to perform, as the devices were not at hand for investigation.However, based on the available information the investigation was conducted with outcome as follows.Dhr review: as no lot numbers were provided for the devices, the device history records could not be reviewed.Compatibility check: the compatibility check could not be performed as only one product was reported to us.The product compatibility check is not relevant for one product only.Review of incoming information: a journal article was received.It was reported that patient had a revision 3.8 years after primary implantation to aseptic loosening of humeral component devices analysis: the device analysis could not be performed as no product was available for investigation.Possible causes for the reported event according to sap dfmea # (b)(4).Accelerated wear leading to improper function of implant and/or loosening -> due to incorrect design.Not possible, a systemic issue with design and/or material properties would have been detected within the complaint summary.Aseptic loosening or cement failure -> due to inadequate surface finish or wrong geometry for required use.Not possible, as the material compatibility specification certify the suitability of the material and the documents of material.Moreover, a systemic issue with design and/or material properties would have been detected within the complaint summary.Accelerated wear leading to improper function of implant and/or loosening -> due to incorrect patient behaviour.Possible, as 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 were unknown.Accelerated wear leading to improper function of implant and/or loosening -> due to wrong positioning/size.Possible, neither x-rays, operative notes,nor photos of the explanted implant were received 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

A journal article of shoulder and elbow surgery was received.The journal reported that one patient was revised to another gsbiii with femoral head impaction bone grafting, for aseptic loosening of the humeral component 3.8 years after the index operation.The received journal was "the long-term outcome of the gschwend-scheier-bĈler iii elbow replacement" (ewan bigsby, mark kemp, nashat siddiqui, neil blewitt, frcs - tr orth).

• Brand Name: ULNA GSB-III
• Type of Device: GSB ELBOW
• 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: 5465899
• MDR Text Key: 39197599
• Report Number: 9613350-2016-00405
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physicist
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention