MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 22/265, TAPER 12/14; WAGNER SL REVISION STEM LATERAL

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Injury (2348)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, 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 cmp-(b)(4).

Event Description

It was reported that during a surgery on (b)(6) 2017, the wagner sl revision stem would not mate with the provisional prosthesis and did not fit in the femur.The surgery was completed with a smaller sized stem with a delay of one hour.

Manufacturer Narrative

Investigation were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: a wagner sl revision stem 22/265 (ref: 01.00102.622 lot: 2665681) has been received.It has been reported that patient underwent hip replacement surgery on (b)(6) 2017.The provisional prosthesis #22 was implanted smoothly, but the prosthesis (wagner sl revision l265mm, 22mm) couldn¿t be implanted.It was found to be much bigger than the provisional prosthesis.Finally, the surgery was completed with a smaller size prosthesis.However, the medullary cavity filling situation was not good and it caused one hour delay.Review of received data: pictures of the wagner sl revision stem have been received.Devices analysis: - visual examination: the wagner sl revision stem shows normal signs of usage.No considerable deteriorations, deformations or imperfections can be seen.- measurements: to ensure the insert has correct dimensions, relevant characteristic according to the inspection plan were measured.Characteristic no.23 feature "dimension (20.58 +0.3/0)¿.-specification: max.20.88 mm; min.20.58 mm.-measured value: 20.58 mm.Characteristic no.25 feature "dimension (24.58 +0.2/-0.1)¿.-specification: max.24.78 mm; min.24.48mm.-measured value: 24.58 mm.Characteristic no.26 feature "dimension (18.00 +0.3/0)¿.-specification: max.18.3 mm; min.18.00 mm.-measured value: 18.23 mm.Characteristic no.27 feature "dimension (22.00 +0.2/-0.1)¿.-specification: max.22.2 mm; min.21.9 mm.-measured value: 21.92 mm.Characteristic no.28 feature "dimension (12.55 +0.3/0)¿.-specification: max.12.85 mm; min.12.55 mm -measured value: 12.55 mm.Characteristic no.29 feature "dimension (18.37 +0.2/-0.1)¿.-specification: max.18.57 mm; min.18.27 mm.-measured value: 18.34 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 occuring during the surgery.Review of product documentation: - compatibility: no compatibility check can be performed as only one product has been reported.- inspection plan: - characteristic no.23 feature "dimension (20.58 +0.3/0)¿ with scope of testing: aql1.0 means of inspection: "3d messmaschine".- characteristic no.25 feature "dimension (24.58 +0.2/-0.1)¿ with scope of testing: aql1.0.Means of inspection: ¿3d messmaschine¿.- characteristic no.26 feature "dimension (18.00 +0.3/0)¿ with scope of testing: aql1.0.Means of inspection: ¿3d messmaschine¿.- characteristic no.27 feature "dimension (22.00 +0.2/-0.1)¿ with scope of testing: aql1.0.Means of inspection: ¿3d messmaschine¿.- characteristic no.28 feature "dimension (12.55 +0.3/0)¿ with scope of testing: aql1.0.Means of inspection: ¿3d messmaschine¿.- characteristic no.29 feature "dimension (18.37 +0.2/-0.1)¿ with scope of testing: aql1.0.Means of inspection: ¿3d messmaschine¿.- funtional relationship analysis (fra) documents: the analysis protocol and resultant fit analysis evaluate the functional relationship between the scope of wagner sl revision stems and the trial stems.Root cause analysis: root cause determination using dfmea: - wrong combination of implant and instruments due to lms marking is not readable under or lighting, marking parameters are not sufficient enough => not possible: as the user states he applied a trial of correct size 22 and the used wagner sl revision stem is correctly labeled, containing the right information (dimension 22/265).However, it could still be that the provisional prosthesis parameters were not well readable so a wrong size was chosen.Moreover as the trial stem has not been received this cannot be further investigated.- migration of stem short and long term, splitting of femur, improper initial setting of the impant due to awl design doesn't correspond to the stem design (functionality) => not possible: as the awl is designed based on the stem.In addition the trial stem had had a proper fit in the femur this indicates the awl¿s dimensions did correspond to the trial¿s and the stem¿s design.- malfunctioning of the device due to wrong handling of device due to wrong information => possible: as the wagner sl revision stem is labeled with correct information and the parameters are well readable.This indicates that either the surgeon or or staff was unfamiliar with implantation technique, which lead to inappropriate use of the provisional prosthesis (trial wagner stem).- wrong combination of the components due to lms marking is not readable under or lighting, marking parameters are not sufficient enough => possible: as the wagner sl revision stem is labeled with correct information and the parameters are well readable.This indicates that either the surgeon or or staff was unfamiliar with implantation technique, which lead to inappropriate use of the provisional prosthesis (trial wagner stem).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" compared to product dimensions reported in inspection plan.As stated in the functional relationship analysis, the nominal cross-section dimensions are the same for the modular trial stem and the implant.Moreover, the number of longitudinal ribs is reduced in order to avoid any jeopardizing effect of the prepared cavity.For these reasons, two possible root causes could explain the reported complaint: first, the trial wagner stem could have been undersized (or mislabeled), leading the wagner sl revision stem to be "bigger" than the undersized provisional stem, or; second, due to the reduced number of longitudinal ribs in the trial wagner stem, higher force than expected by the surgen could have resulted when inserting the wagner sl revision stem into the pre-drilled cavity.These increased forces could have led the surgeon to conclude that the wagner sl revision stem was bigger than the provisional prosthesis, which in reality was not.As the trial stem has not been received the root cause cannot be further investigated.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).

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 22/265, TAPER 12/14
• Type of Device: WAGNER SL REVISION STEM LATERAL
• 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: 6386830
• MDR Text Key: 69337733
• Report Number: 0009613350-2017-00354
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.622
• Device Lot Number: 2665681
• Other Device ID Number: 00889024430822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2012
• 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): Other
• Patient Age: 76 YR
• Patient Weight: 80