MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP PROSTHESIS STEM

Model Number 172-916/12

Device Problems Accessory Incompatible (1004); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

For the smallest available stem size (art.No.172-916/12) the reaming guide and the guide rod can't be screwed into the intended depth.The reason for this is a reduced depth of the core hole in the stem.A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly.Corrective reaming can lead to a surgery time extension.The correct fit of the neck can't be verified by means of the guide rod.This failure can only occur with the smallest available stem size (art.No.172-916/12).Initiation of the corrective and preventive action: capa-(b)(4).

Event Description

Translation: during the surgery of 160/12 mp hip stem, both reaming guides and the guide rod could not be screwed into the trial stem or the original stem until the required final position was reached.On the one hand, this results in an incomplete metaphyseal reaming of the neck part, on the other hand, the correct seating of the neck can not be controlled with the guide rod.In situ, unfortunately, no usable photos could be taken with the original stem.Useful photos with the trial stem on the sterilizing table are included in the attachment.There you can see that the tip of the reaming guide in the depth contacts the bottom of the threaded hole of the trial stem.For all other stem sizes the reaming guide and the guide rod can be screwed in correctly to the final position.(link representative (b)(6)).

• Brand Name: MP PROSTHESIS STEM
• Type of Device: MP PROSTHESIS STEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer (Section G): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike kleine ; barkhausenweg 10; hamburg, ; GM
• MDR Report Key: 8100937
• MDR Text Key: 129346954
• Report Number: 3004371426-2018-00016
• Device Sequence Number: 0
• Product Code: LWJ
• Reporter Country Code: GM
• PMA/PMN Number: K142187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: 172-916/12
• Device Catalogue Number: 172-916/12
• Device Lot Number: 1726056
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1