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

Model Number	NH156T
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9610612-2022-00068
• Device Sequence Number: 3836938
• Product Code: LWJ
• UDI-Device Identifier: 04038653206193
• UDI-Public: 4038653206193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA770T, BATCH 51493457; NA770T, BATCH 51501131; NH194, BATCH 51408848; NJ133K, BATCH 51475043
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown