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

Model Number NC272T

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: due to the circumstance that we did not received any explants, an investigation at the sample is not possible.This case was discussed with a specialist from the marketing department.The x-ray shows bilateral metha tha in a male patient.Exact date of index surgeries (both hips) is not confirmed.As the x-ray is from 2014 and the current case information from 2017 we assume a current time in vivo of about 4 years.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available the root cause of the failure is probably not product related.Rational: both hip stems show evident radiological signs of stem loosening with a clear radiolucent line formation at gruen zone 1 proximal-lateral.Right hip stem has a lateral-distal pedestal bone formation which may be interpreted as a secondary radiological sign of implant loosening.Therefore both hip stems may be loose and should therefore show clear clinical symptoms of pain in both hip joint during load and walking.Cup implants also show certain but unclear radiological signs of bone interface changes in charnley zones ii at the bottom of the pressfit shell.Based on the x-ray information from 2014 we assume an evolution of early bilateral stem loosening.Based on available clinical studies of the metha hip stem this is a rare situation and may happen within the first postoperative year.A possible root cause for this failure could be an excessive load to the hip prosthesis shortly after implantation.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 2
• 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: 6585280
• MDR Text Key: 75774594
• Report Number: 9610612-2017-00294
• 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: 08/02/2017

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: NC272T
• Device Catalogue Number: NC272T
• 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