MAUDE Adverse Event Report: ZIMMER GMBH CLS SPOTORNO, STEM, 135, UNCEMENTED, 10.0, TAPER 12/14; CLS SPOTORNO STEM

Model Number N/A

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient was not revised.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.According to the provided information, the current situation reflects an off-label use, i.E.Contraindicated use as described in zimmer's instruction for use.Zimmer's reference number of this file is (b)(4).This is a bilateral patient.Right hip case is reported under (b)(4).

Event Description

The patient is pursuing a product liability claim.The patient was implanted a cls spotorno, stem, 135, uncemented, 10.0, taper 12/14 on (b)(6) 2008.A revision surgery was planned on an unknown date due to unknown reasons.It was also reported that the surgeon combined the stem with competitor's products.According to the provided information, the current situation reflects an off-label use.Since the exact date of the event was not reported, it will be entered as the date of awareness.

Manufacturer Narrative

Investigation results were made available.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend was identified.Review of event description: it was reported that the patient was implanted a cementless hip tep on left hip on (b)(6) 2008.Competitor's product were combined with the zimmer biomet stem.The patient suffers from pain.Review of received data: only an attorney letter and the product stickers were received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was not approved by zimmer biomet.The instruction for use for cls stems was reviewed; it states that ¿only authorized combinations must be used.To determine whether these devices have been authorized for use in a proposed combination, please contact your zimmer sales representative or visit the zimmer website: www.Productcompatibility.Zimmer.Com.¿ root cause determination using dfmea: aseptic loosening due to surgeon does not comply to surgical technique (early stability) => possible: the cls stem was combined with competitor's products.Failure of connection between stem and ball head due to improper connection of ball head during surgery => possible: the cls stem was combined with competitor's products.Aseptic loosening, migration of stem short and long term due to wrong handling of the stem, splitting of femur due to surgeon does not comply to surgical technique => possible: the cls stem was combined with competitor's products.Migration of stem short and long term, splitting of femur due to surgeon chooses wrong indications => possible: the cls stem was combined with competitor's products.Migration/subsidence of stem short and long term, splitting of femur due to wrong size implanted (wrong size chosen) => possible: the x-rays and surgical reports were not available, therefore cannot be excluded.Conclusion summary: it was reported that the cls stem was combined with competitor's products.Therefore, we consider the root cause for this case as off-label use.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: CLS SPOTORNO, STEM, 135, UNCEMENTED, 10.0, TAPER 12/14
• Type of Device: CLS SPOTORNO STEM
• 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: 5652409
• MDR Text Key: 45111455
• Report Number: 0009613350-2016-00679
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 29.00.39-100
• Device Lot Number: 2413768
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2007
• 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: 60 YR