MAUDE Adverse Event Report: AESCULAP AG SC/MSC PE-INSERT 28MM 56/58 ASYM.; HIP ENDOPROSTHESES - ACETABULA

Model Number NH474

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product sc/msc pe-insert.According to the complaint description the acetabular cup replacement is scheduled to be conducted for a patient who had total hip arthroplasty (tha) on (b)(6) 2009.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Involved components nj015t- bicontact n plasmapore 8/10 size 15mm- 51508869a.Nj102- biolox prosthesis head 8/10 28mm m- 51523514.General information we received a complaint about a nh474 - sc/msc pe-insert 28mm 56/58 asym.Regarding a revision surgery 10 years and 7 months post-operatively.We did not receive the components for investigation.Consequences for the patient post-operative medical intervention was necessary à revision surgery.Failure description due to a lack of components, a failure description is not possible.Investigation due to a lack of components, an investigation is not possible.Batch history review the device history records have been checked for the available lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number of the pe-insert (51477463).Conclusion and root cause the failure is most probably usage / patient related.Rationale based on the information provided and without the product for investigation a clear conclusion can not be drawn.There is no indication for a material or manufacturing failure on the basis of the dhr review.As mentioned by the surgeon (see figure 1) the occurred dislocations may be traced back to the implantation situation and the cup angle, therefore we assess this as the most probable root cause.

• Brand Name: SC/MSC PE-INSERT 28MM 56/58 ASYM.
• Type of Device: HIP ENDOPROSTHESES - ACETABULA
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9933153
• MDR Text Key: 187416617
• Report Number: 9610612-2020-00099
• 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: 06/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NH474
• Device Catalogue Number: NH474
• Device Lot Number: 51477463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NJ015T-51508869A; NJ102-51523514
• Patient Outcome(s): Other; Required Intervention