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

Model Number NC088K

Device Problems Metal Shedding Debris (1804); Material Integrity Problem (2978)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).It was reported that there is possible metallosis issued on a metha modular; the implant was performed on 2011.All med watch submissions rlated to this report are: 9610612-2018-00008, 9610612-2018-00009.

Manufacturer Narrative

Investigation: no product is at hand.Batch history review: the device history records have been checked and found to be according to the specification valid at the time of production.No similar incidents are filed with products from these batches.Conclusion and root cause: based on the information available, the root cause is most probably user or patient related.An example of a user error could be an implant malfunction due to an insufficiently fixated cone adapter.Based on our experience, micro movements between the neck adapter and the metal stem could facilitate an iron contribution.However, we have not enough information to fully evaluate this case, we do not know if the patient has another prosthese etc.Rational: there are no hints of a product or material deviation.No capa is necessary.

• 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 AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7158814
• MDR Text Key: 96234433
• Report Number: 9610612-2018-00008
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/20/2018

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: 07/01/2020
• Device Model Number: NC088K
• Device Catalogue Number: NC088K
• Device Lot Number: 51686521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/02/2018
• Device Age: 7 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2010
• 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