MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS METHA ¿CAP 12/14 130°/0° SIZE 2; HIP ENDOPROSTHESIS

Model Number NC272T

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

Event Type  Injury  

Event Description

Country of complaint: (b)(6).Seven month post operative loosening of hip stem.Involved component (listed as concomitant product): nk562d / biolox delta prosth.Head 12/14 32mm l.

Manufacturer Narrative

Investigation: this case was discussed with a specialist from the marketing department.The stem shows only a small quantity of bony adhesion.Furthermore there are traces of titanium on the ceramic ball head which confirm the loose prosthesis.The x-rays are unfortunately in a poor quality.Therefore an evaluation is only possible to a limited extent.But we assume that the stem is implanted in a proper way.The surgery report of the explantation describes a stem which is obviously not integrated into the bony tissue.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: we exclude a product- or design related error.An aseptic loosening respective a not integrated stem into the bony tissue in the first postoperative year is a typical early complication.This complication is described in follow up studies with an incidence of approx 1%.A possible root cause for this failure could be an excessive load to the hip prosthesis shortly after implantation.Corrective action: a capa is not necessary.

• Brand Name: METHA ¿CAP 12/14 130°/0° SIZE 2
• Type of Device: HIP ENDOPROSTHESIS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5706062
• MDR Text Key: 46787475
• Report Number: 3005673311-2016-00087
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NC272T
• Device Catalogue Number: NC272T
• Device Lot Number: 52116264
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2016
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR