MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS METHA NECK 12/14 135°/0°; HIP ENDOPROSTHESIS

Model Number NC088K

Device Problem Device Issue (2379)

Patient Problem No Code Available (3191)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).8 to 9 year post operative metal corrosion of the neck of the implant.Original implant date: 2007.Patient was initially symptom-free.Resection of tumor-like growth in 2015 was completed and there was histological evidence of metal and bone particles present.Components involved: nc088k / metha neck 12/14 135 deg/0 deg, lot number : 51406439 (black discoloration on the surface of the neck).Nc082t / metha short hip stem p size 2, lot number: 51381308.Nh448t / screw cup sc size 48mm, lot number 51408938 (cup was loosened).Nh102d / sc/msc biolox delta ins.32mm 48/50 sym.Lot number 51375692.Nk560 / biolox prosthesis head 12/14 32mm s, lot number 51375689 (macroscopic metal parts on the ceramic head).

Manufacturer Narrative

Investigation all available components were investigated microscopically.Furthermore this case was discussed with specialists from r&d and the marketing department.Batch history review: the device history records have been checked and were found to be according to the specifications valid at the time of production.No similar incidents are filed with products from these batches.Conclusion and root cause: this failure might be most likely patient or user related rational: the available information is not insufficient to determine a final root cause.There are no hints for a product or material deviation.Therefore we assume that the patient related condition might be responsible for the failure.Corrective action according to sp sa-de13-m-4-2-01-000-0, a capa is not necessary.

• Brand Name: METHA NECK 12/14 135°/0°
• 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: 5475728
• MDR Text Key: 39519442
• Report Number: 3005673311-2016-00028
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071916
• 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: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/30/2017
• Device Model Number: NC088K
• Device Catalogue Number: NC088K
• Device Lot Number: 51406439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/22/2016
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 57 YR
• Patient Weight: 67