MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS SC/MSC PE-INSERT 28MM 44/46 ASYM.; HIP ENDOPROSTHESIS

Model Number NH471

Device Problems Break (1069); Fitting Problem (2183)

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

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Revision surgery (hip) due to ceramic breakage was being performed and when the surgeon was trying to insert the product (pe insert) into the metal shell, it would not fit.Several attempts were made to insert from different directions, however, were unsuccesful.The surgery was completed using a 0 degree insert.Closed reduction was necessary due to anterior luxation after surgery.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the implant.Here we found visible damage and a scratch.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according the quality standard and dhr files, a material defect or production error can be excluded.No similar incidents have been filed with products from this batch.We assume that the visible damages were caused due to the implantation.For the failed fitting there is the possibility of an impure inner cone of the exterior cup.No capa is necessary.

• Brand Name: SC/MSC PE-INSERT 28MM 44/46 ASYM.
• Type of Device: HIP ENDOPROSTHESIS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5157108
• MDR Text Key: 28853097
• Report Number: 3005673311-2015-00163
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K042344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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: No Information
• Device Expiration Date: 05/01/2019
• Device Model Number: NH471
• Device Catalogue Number: NH471
• Device Lot Number: 52047396
• Initial Date Manufacturer Received: 09/18/2015
• Initial Date FDA Received: 10/16/2015
• Supplement Dates Manufacturer Received: 09/18/2015
• Supplement Dates FDA Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR