MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM, UNCEMENTED, 2, TAPER 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Investigation results were made available. Trend analysis: no trend identified. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. Review of event description: it was reported that a (b)(6) years old female patient received tha on right hip (alloclassic sl stem, metasul insert, me head, allofit-s shell) on (b)(6) 2000 and underwent a revision surgery on (b)(6) 2017 due to wear after 17 years 2 months in-vivo time. Patient was unhappy with the tha and felt that operative leg is too short. Both cup and stem were well fixed. Liner and stem were removed. New stem implanted, lengthening leg by approximately 20mm and now matching the length of the non-operative leg. Neutral liner was inserted. It was noted that the stem trunnion shows evidence of trunnionosis. Some black material was observed inside the head and at base of trunnion. Review of received data: a picture of the explanted products was received. No comments on the condition of items can be done since they are covered in blood. Implant stickers belonging to the primary surgery were received. Devices analysis: no product was returned to zimmer biomet for in-depth analysis. Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet. Root cause analysis: root cause determination using dfmea: luxation and wear of components due to insufficient range of motion for components
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> possible: no x-rays were received to confirm, therefore cannot be excluded. Excessive wear, disassembly of femoral head from stem, implant failure due to combination with competitor products (off label use)
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> not possible: combination of the products is allowed. Conclusion summary: according to the reported event, during the revision surgery evidence of trunnioinosis was observed. Neither products nor surgical reports were received to confirm the event. From the photo of the explanted devices it is not possible to make any comments regarding the failure type. However, most likely reason for the reported event is the insufficient range of motion for components which might lead to wear of the components. 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 gmbh considers this case as closed. Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review. A photo was received. The lot number of the device was received. The device history records will be reviewed during investigation. A cause for this specific event cannot be ascertained from the information provided. An e-mail requesting the following additional information was sent on march 30, 2017 to the appropriate representatives. 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 alloclassic, sl stem, uncemented, 2, taper 12/14 on the right side on (b)(6) 2000. The patient was revised on unknown date due to trunnionosis.

Manufacturer Narrative

As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4).

Event Description

It was now reported that the revision surgery occurred on (b)(6) 2017.

• Brand Name: ALLOCLASSIC SL STEM, UNCEMENTED, 2, TAPER 12/14
• Type of Device: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL 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: 6452972
• MDR Text Key: 200212107
• Report Number: 0009613350-2017-00475
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/15/2004
• Device Model Number: N/A
• Device Catalogue Number: 28.42
• Device Lot Number: B367354
• Other Device ID Number: 00889024465558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/1999
• 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 Treatment Data

Date Received: 04/03/2017 Patient Sequence Number: 1