MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS METHA ¿CAP 12/14 130°/0° SIZE 1; IMPLANTS METHA

Model Number NC271T

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/21/2017

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 about 5 years later, the patient has a problem with osteolysis so there is loosening on both sides of the knee.No revision surgery has been scheduled.All med watch submissions related to this report are: 9610612-2017-00293, 9610612-2017-00294.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope.The breakage surface of both devices shows a transgranular forced fracture.The direction of the breakage is from outside to the inside.The broken pieces are not available.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably user related.Rational: this type of damage indicates an user related error.We assume that the device was hammered in too hard and therefore mechanically overloaded.Corrective action.According to sop sa-de13-m-4-2-01-010 a capa is not necessary.

• Brand Name: METHA ¿CAP 12/14 130°/0° SIZE 1
• 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: 6585277
• MDR Text Key: 75859659
• Report Number: 9610612-2017-00293
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NC271T
• Device Catalogue Number: NC271T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/18/2017
• Date Manufacturer Received: 01/21/2017
• 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: 43 YR
• Patient Weight: 74