MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS SC/MSC PE-INSERT 32MM 48/50 SYM.; HIP ENDOPROSTHESES

Model Number NH202

Device Problem Break (1069)

Patient Problem Missing Value Reason (3192)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Implant (inlay) breakage after 4 years 4 months 3 weeks of being implanted.Original surgery date: (b)(6) 2011.Revision surgery date: (b)(6) 2016.Involved components: nk512t / bicontact s plasmapore 12/14 size 12mm / lot number 51713447 (not marketed in the u.S.).Nh048t / plasmacup sc size 48mm / lot number 51760438.Nk529k / isodur prosthesis head 12/14 32mm s / lot number 51746419.

Manufacturer Narrative

Investigation: this case was discussed with specialist from the product management.Both components were investigated visually.The pe insert shows visible wear marks and abrasions.Furthermore a curvature is visible which indicates a lever out of the insert from the cup.In the sliding surface there are only little metal wear marks.This means that there is no third-body wear.The prothesis head shows visible surface changes respective a rough surface which may be caused by contact with the rim of the plasmacup.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this these batches.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 not product related.It could be possible that the insert tilted inside the acetabular cup because of luxation.Rational: we exclude a material or manufacturing problem, because the quality manufacturing documents have been checked and were found to be according to the valid specifications.There were no other complaints within this batch.Therefore a design, product or material failure can be excluded.Corrective action: according to sop sa-de13-m-4-2-01-010 a capa is not necessary.

• Brand Name: SC/MSC PE-INSERT 32MM 48/50 SYM.
• Type of Device: HIP ENDOPROSTHESES
• 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: 5571924
• MDR Text Key: 42489156
• Report Number: 3005673311-2016-00062
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042344
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/01/2016
• Device Model Number: NH202
• Device Catalogue Number: NH202
• Device Lot Number: 51756517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/08/2016
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2011
• 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: 70 YR