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

Model Number NC088K

Device Problem Material Discolored (1170)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.The device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication for a material defect or a manufacturing error.No further complaints registered against the mentioned lot number.Based on the information currently available, the root cause is probably user using or patient related.There are no hints for a product or material deviation.Based on the experienced, micro movements between the neck adaptor and the metal stem could facilitate corrosion.Micro movements can be triggered due to tissue resides within the cone/stem connection intraoperatively.The surgeon have to ensure that the cone is clean and rinsed according to the ifu valid at the time of the surgery.Furthermore an overload situation after the surgery can also lead to micro movements and therefore to corrosion.In general due to the few information available it is not possible to fully evaluate this case to date.After we receive the prosthesis, the case will be e-opened and a further investigation will be executed.A capa is not necessary.

Event Description

Country of complaint: (b)(6).During an arthroscopy, corrosion was probably discovered in the transition between shaft and neck.The implant is still in the patient - revision is scheduled, we will receive the explantate.Revision: (b)(6) 2018.No laboratory values of urine available.Patient: (b)(6), female, (b)(6), initial implantation: (b)(6) 2011.In (b)(6) 2018, the patient reports on groin pain that has already existed for about half a year.The suspicion of a psoas impingement was expressed and thus the indication for arthroscopy was asked.All medwatch submissions related to this report are: 9610612-2018-00330; 9610612-2018-00331.

• Brand Name: METHA NECK 12/14 135°/0°
• Type of Device: IMPLANTS METHA
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7727585
• MDR Text Key: 115538855
• Report Number: 9610612-2018-00330
• 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
• Report Date: 07/26/2018

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: 03/01/2021
• Device Model Number: NC088K
• Device Catalogue Number: NC088K
• Device Lot Number: 51746381
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2018
• Device Age: 7 YR
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2011
• 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: 68 YR