MAUDE Adverse Event Report: AESCULAP AG PLASMACUP MSC SIZE 56MM; HIP ENDOPROSTHETICS

Model Number NH156T

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Failure of Implant (1924)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual investigation: the components show severe damage.The components were examined visually and microscopically.Micro-movements caused by a loosened or not completely screwed in screw could have caused this material removal between plasmacup and the screw.In view of the fact that the shaft is not available for examination, no opinion can be given on this.In order to be able to make a more precise statement, a histology should be made of the tissue, from which it is clear what type of deposits in the tissue it is (cobalt chromium steel or titanium).Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

It was reported to aesculap ag that a plasmacup msc size 56mm (part # nh156t) was implanted during a total hip arthroplasty (tha) procedure performed on (b)(6) 2008.According to the complainant, the patient fell postoperatively and underwent a revision of the "cup side".At the time of the revision, the surgeon noted that osteolysis may have occurred; metallosis was also possible.An additional medical intervention was required.The patient did not have an infection.The malfunction is filed under aag reference (b)(4).Involved components: isodur prosthesis head 8/10 28mm l - nj133k, batch 51475043.Sc/msc pe-insert 28mm 56/58 sym.- nh194, batch 51408848.Plasmacup fixation screw 6.5x20mm - na770t, batch 51493457.Plasmacup fixation screw 6.5x20mm - na770t, batch 51501131.

• Brand Name: PLASMACUP MSC SIZE 56MM
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13805993
• MDR Text Key: 288619770
• Report Number: 9610612-2022-00068
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 04038653206193
• UDI-Public: 4038653206193
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2022

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 Expiration Date: 06/30/2018
• Device Model Number: NH156T
• Device Catalogue Number: NH156T
• Device Lot Number: 51502096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2008
• 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
• Treatment: NA770T, BATCH 51493457; NA770T, BATCH 51501131; NH194, BATCH 51408848; NJ133K, BATCH 51475043
• Patient Outcome(s): Required Intervention