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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION, AWL, 16

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ZIMMER GMBH WAGNER SL REVISION, AWL, 16 Back to Search Results
Model Number N/A
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2017
Event Type  malfunction  
Manufacturer Narrative
Device history records (dhr): as no lot numbers was provided for this devices, the device history records could not be reviewed. The missing device information has been requested but was not available. At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures. Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold. These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors. Thus, for all products sold to the market can be assumed having a complete and correct dhr. Trend analysis: no trend identified. Review of event description: a wagner sl revision stem (ref: 01. 00101. 916 lot: 2782216) has been received. It has been reported that in a hip revision surgery the awl ("drill") 16 and the stem 16 did not fit / match together, and it was necessary to use a stem 18. This caused a surgical delay of 20 minutes. Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received. Devices analysis: visual examination: the wagner sl revision stem shows few normal signs of usage further no considerable deteriorations, deformations or imperfections can be seen. The involved awl of size 16 has not been returned. To ensure the stem has correct dimensions, relevant characteristic according to the inspection plan were measured. Characteristic no. 23 feature "dimension (13. 4 +0. 3/0)¿, specification: max. 13. 7 mm; min. 13. 4 mm, measured value: 13. 60 mm. Characteristic no. 25 feature "dimension (16. 0 +0. 2/-0. 1)¿, specification: max. 16. 2 mm; min. 15. 9 mm, measured value: 16. 06 mm. Characteristic no. 29 feature "dimension (12. 37 +0. 2/-0. 1)¿, specification: max. 12. 47 mm; min. 12. 27 mm, measured value: 12. 37 mm. Characteristic no. 28 feature "dimension (9. 77 +0. 3/0)¿, specification: max. 10. 07 mm; min. 9. 77 mm, measured value: 9. 94 mm. Conclusion: based on the diameters as measured above, the correct size of the stem can be confirmed. Further the dhr indicates that all components met all specifications. Functional test: a functional test was not performed as the measurements indicate that the implant components met all specifications, and it was not possible to re-create the situation occurring during the surgery. Review of inspection plan for ref 01. 00101. 916: characteristic no. 23 feature "dimension (13. 4 +0. 3/0)¿ with scope of testing: aql1. 0 means of inspection: "3d messmaschine". Characteristic no. 25 feature "dimension (16. 0 +0. 2/-0. 1)¿ with scope of testing: aql1. 0. Means of inspection: ¿3d messmaschine¿. Characteristic no. 29 feature "dimension (12. 37 +0. 2/-0. 1)¿ with scope of testing: aql1. 0. Means of inspection: ¿3d messmaschine¿. Characteristic no. 28 feature "dimension (9. 77 +0. 3/0)¿ with scope of testing: aql1. 0. Means of inspection: ¿3d messmaschine¿. Review of inspection plan sap document for ref 01. 00109. 016: characteristic no. 9 feature "diameter (ø13. 66 +0. 06/-0. 06)¿ with scope of testing: aql1. 0. Means of inspection: ¿winkellehre typ b¿ characteristic no. 10 feature "diameter (ø15. 75 +0. 15/-0. 15)¿ with scope of testing: aql1. 0. Means of inspection: ¿winkellehre typ b¿ characteristic no. 20 feature "diameter (ø17 +0. 2/-0. 2)¿ with scope of testing: aql2. 5. Means of inspection: ¿2d messprojektor¿ review of surgical techniques: in surgical technique it is described: "to check the depth of implantation and exact positioning of the prosthesis, the modular trial prosthesis are used. A trial prosthesis corresponding to the prosthesis size defined in pre-operative planning is assembled in advance, with a diameter corresponding to the awl last used, and inserted into the prepared medullary cavity. " functional relationship analysis: the analysis protocol and resultant fit analysis evaluate the functional relationship between the scope of wagner sl revision stems and the awl. It is stated: "the difference in cross sections of each implant wagner sl revision stem at nominal conditions and instrument awl sl revision stem at nominal conditions is 0. 25mm in diameter (0. 125mm in radius). Awls are effective under ream relative to implant and are smaller in diameter. The acceptance criterion of 0. 2 to 0. 3mm for diameter difference between implant and awl has been met. " root cause analysis: root cause determination using dfmea for ref 01. 00101. 916: wrong combination of implant and instruments due to lms marking is not readable under or lighting, marking. Parameters are not sufficient enough. Possible: for the wagner sl revision stem it can be confirmed it is labeled with correct information and the parameters are well readable. However, as the reported awl has not been returned it is possible it's lms marking was not readable so a wrong size was chosen during surgery. Migration of stem short and long term, splitting of femur, improper initial setting of the implant due to awl design doesn't correspond to the stem design (functionality). Not possible: as the functional relationship analysis confirms the awl's design correspond to the stem design. Malfunctioning of the device due to wrong handling of device due to wrong information, not possible: as nothing indicates the stem was handled wrongly. However, the reported event indicates the surgeon missed a relevant step (use of the trial prosthesis) and this might have played a role regarding the improper initial setting of the stem size 16. Wrong combination of the components due to lms marking is not readable under or lighting, marking parameters are not sufficient enough, possible. For the wagner sl revision stem it can be confirmed it is labeled with correct information and the parameters are well readable. However, as the reported awl has not been returned it is possible it's lms marking was not readable so a wrong size was chosen during surgery. Root cause determination using dfmea for ref 01. 00109. 016: instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition, not possible. As the functional relationship analysis (fra) confirms the awl's design correspond to the stem design. Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling, possible. As it cannot be excluded based on the available information. Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling, possible. As it cannot be excluded based on the available information. Conclusion summary: based on the returned product and the given information, the complaint could not be confirmed. The visual examination and the measurements did not confirm that the wagner sl revision stem was "oversized/ undersized" compared to product dimensions reported in inspection plan. Also the functional relationship analysis confirms the awl's design correspond to the stem's design. As the reported awl of size 16 has not been returned it is possible it was wrongly dimensioned or it's lms marking was worn/ not readable so a wrong size was chosen during surgery. Moreover, as the reported event does not mention any trial stem it is possible the surgeon missed this relevant step during surgery. Using a trial before setting the final implant would have supported the surgeon in assessing the correct position of the final implant. So in case this step was missed, it might have played a role regarding the improper initial setting of the stem size 16. 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 during an implantation surgery on (b)(6) 2017, the wagner sl revision hip stem, was not fitting/matching with the drill size 16 (wagner sl revision, awl, 16). The surgery was completed with another stem (size 18) and with a delay of 20 minutes.
 
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Brand NameWAGNER SL REVISION, AWL, 16
Type of DeviceWAGNER SL REVISION, AWL
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6889683
MDR Text Key89313558
Report Number0009613350-2017-01320
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number01.00109.016
Device Lot NumberUNKNOWN
Other Device ID Number00889024277656
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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