MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC, SL STEM, UNCEMENTED, 5, TAPER 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomets reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a alloclassic, sl stem, uncemented, 5, taper 12/14 on an unknown side on an unknown date and that head neck did not fit properly to alloclassic stem neck.

Manufacturer Narrative

Investigation results were made available.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive additional information for this case.The missing information was requested at complainant the latest one on (b)(6) 2017 but was not available.Device history records: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: during surgery, it was found that head neck did not fit properly to alloclassic stem neck.Surgery was delayed due to fitting issue.This is a split case with zimmer inc., (b)(4) with reference number (b)(4) (head).Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.The missing information has been requested but was not available.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the information received, the product location is unknown (presumedly implanted).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 rmw: intraoperative complications due to incorrect associated instruments used possible, no detail about the implantation surgery are available.Therefore this cannot be excluded.Intraoperative complications due to design specification not met.Not possible.A systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Intraoperative complications due to missing component in set package.Not possible.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Intraoperative complications due to inadequate handling during transport/storage possible, the device manufacturing quality records indicate that the released components met all requirements to perform as intended.However, inadequate handling cannot be excluded.Intraoperative complications due to excessive attachment force possible, no detail about the implantation surgery are available.Therefore this cannot be excluded.Intraoperative complications due to wrong handling of instrumentation possible, no detail about the implantation surgery are available.Therefore this cannot be excluded.Intraoperative complications due to inappropriate information on packaging label or not legible packaging label leads to incorrect use of implant.Not possible.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Intraoperative complications due to insufficient description of surgical process leads to intraoperative errors or misuse of implant outside of its scope.Not possible.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Conclusion summary: it was reported that during :surgery, it was found that head neck did not fit properly to alloclassic stem neck.Surgery was delayed due to fitting issue.No other detail is available.In conclusion, due to significant lack of information, an exact root cause cannot be determined.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: ALLOCLASSIC, SL STEM, UNCEMENTED, 5, 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6860878
• MDR Text Key: 86091543
• Report Number: 0009613350-2017-01214
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK030373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 2845
• Device Lot Number: 2879479
• Other Device ID Number: 00889024481367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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