MAUDE Adverse Event Report: AESCULAP AG COREHIP VAR CEMENTLESS 12/14 SIZE 7; HIP ENDOPROSTHETICS

Model Number NK1047T

Device Problem Component or Accessory Incompatibility (2897)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the provided devices were delivered in a contaminated condition.The components were decontaminated internally according to internal standards.Investigation: the available components were examined visually and microscopically.The case was also discussed with several specialists from the development department and specialists from the product management group.Only with repeated rotation in several directions with a lot of force was it possible to loosen the connection between the insertion instrument and the implant.The pocket in the implant (connection implant to instrument) show clearly visible material abrasions/damages on all 3 flanks.The working end of the insertion instrument also shows material damages.It was possible to readjust the error during the experiment/test.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to specifications valid at the time of production.No similar incidents have been filed with products from 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 likely usage related.Rationale: according to the quality standard and device history record (dhr) files, a material defect and production error is improbable.At that we exclude a design related error because the market feedback is unremarkable on this matter.It was possible to readjust the error.It appears that the working end of the inserter was positioned in the pocket of the implant in an insufficient way by simultaneously using the hammer.

Event Description

It was reported that there was an issue with implant insertion.During a hip arthroplasty procedure, the implant and insertion instrument did not function together.It was noted that the insertion instrument did not detach from the implant.There was no patient harm or surgical delay.Another implant and instrument were used instead.Associated medwatches: (the implant and inserter were reported separately).

• Brand Name: COREHIP VAR CEMENTLESS 12/14 SIZE 7
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8744451
• MDR Text Key: 149785280
• Report Number: 9610612-2019-00439
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019

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 Model Number: NK1047T
• Device Catalogue Number: NK1047T
• Device Lot Number: 52489769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2019
• 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