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Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive devices, x-rays, or other source documents for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. Additional information has been requested and is not currently available. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. (b)(4).
Event Description
It was reported that the patient was implanted a humerus gsb-iii 76 on an unknown date. The patient was revised on an unknown date due to problem with the articulation, it seems to get stuck during movements.
Manufacturer Narrative
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) in the event information section the (b)(6) 2016 is given as the date alleged event occurred. The description states that the patient was not able to move the extremity which resulted in a revision surgery. It is also stated that there is a problem with the articulation. It seems to get stuck during movements. Review of received data: - video from customer: the short video sequence shows that during surgery an instrument is entered through the bore for the ulnar peg in the hinge of the humeral component. It is then moved by hand with the help of the instrument. Devices analysis: - as received condition: the explants were received in a packaging that is commonly used for autoclaving. The color code of the packaging had a brownish color. This indicates that steam sterilization was performed. - visual examination: the anchoring surfaces of the humeral component are inconspicuous. The hinge is still mounted in the humeral component. The hinge cannot be moved at all by hand. The polyethylene-pin-bushings are deformed in such a way that on the dorsal side the polyethylene fills the gap between hinge and humeral component on one side while on the ventral side both gaps are filled. On the cylindrical surface of the hinge a small polished zone can be recognized. The polyethylene-bushing in the bore for the ulnar peg is missing. On the dorsal side there is a slight deformation on the bore¿s edge. On the ventral side an approximately 1 to 2 mm wide, polished, almost circumferential stripe can be seen on the face surface around the bore. The edge of the bore is polished and slightly deformed on approximately three quarter of its circumference. The bore surface itself is intact. On the hinge and on both humeral gliding surfaces diffuse scratches are visible. The collar of the ulnar component shows some scratches on its circumference as well as slight damage on its bottom side. These can probably be attributed to the revision surgery. The anchoring surfaces of the ulnar component are inconspicuous. The peg of the component exhibits several diffuse scratches. On the face surface of the collar around the peg there is an almost circumferential polished stripe close to the outer edge of the surface. Additionally, three deeper appearing polished lines can be seen on one side. Further, a polished stripe can be noticed close to the peg¿s bottom on both of its small sides as well as one long side. Closer inspection of the stripe with a low power microscope with up to 40x magnification (wild m38, (b)(4)) revealed that due to wear and deformation some material was displaced that forms a little ledge. On the long side of the peg on both ends of the stripe conspicuous areas were identified. The latter were examined with the microscope type leica dmrx (eq-id (b)(4)). It seems that surface changes probably due to surface fatigue, e. G. Pits, occurred. Under certain light conditions it seems that there is a slightly worn, elliptical-shaped area at the peg¿s bottom on the ventral side. Conclusion summary: the elbow prosthesis was revised after unknown time in vivo because the patient could not move the extremity. The explants were received in autoclaved condition. The hinge that is mounted to the humeral component contains two polyethylene-pin-bushings. Polyethylene should not be autoclaved as it expands under the usually applied temperatures during steam sterilization. In the current design the polyethylene becomes deformed due to the limited space. Therefore, it remains unknown if the deformations of the polyethylene-pin-bushings observed during investigation can be completely attributed to the steam sterilization or if there was already some deformation in the as-removed condition. A possible deformation of the polyethylene-pin-bushings in vivo would have changed the clearance between the hinge and the opening in the humeral component. As a consequence this could probably have led to a hindered movement of the prosthesis. However, it remains unknown why the patient was not able to move the extremity and which factors influenced it and / or contributed to it. The polyethylene bushing in the bore for the ulnar peg on the hinge of the humeral component is missing. The reason for that is unknown. The polished, almost circumferential stripe around the bore as well as the polished and deformed edge of the bore correspond to the phenomena seen on the face surface of the ulnar component¿s collar and around the bottom of the ulnar peg. This points to a direct metal-on-metal contact between the components which indicates that the collar of the polyethylene bushing was no longer intact. The reason for this is unknown. Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue. The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).
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Type of DeviceGSB ELBOW
Manufacturer (Section D)
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
kevin escapule
1800 west center street
warsaw, IN 46580
MDR Report Key6217740
MDR Text Key63693776
Report Number0009613350-2017-00005
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2013
Device Model NumberN/A
Device Catalogue Number0536
Device Lot Number2453628
Other Device ID NumberNOT AVAILABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/03/2017 Patient Sequence Number: 1