MAUDE Adverse Event Report: AESCULAP AG VITELENE INSERT E 32MM POST.WALL; HIP ENDOPROSTHESES - ACETABULA

Model Number	NV301E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.If relevant additional information / investigation results are provided, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a plasmafit poly cup (part # nv046t) was implanted during an orthopedic procedure performed on (b)(6) 2021.According to the complainant, the vitelene inlay (part # nv301e) was not able to be inserted.The procedure was successfully completed using another vitelene inlay.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information has been requested, but has not yet been received.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00158 (400503264 + nv301e), 9610612-2021-00104 (400501782 + nv046t).
Additional Manufacturer Narrative
Investigation results: leading component: nv301e - vitelene insert e 32mm post.Wall.Involved component: nv046t - plasmafit poly cup size 46mm e.Visual investigation: the provided implant shows no serious outwardly obvious damage.The component was examined visually and microscopically.Nv046t and nv301e are an approved combination and may be used together.The complained inlay shows no damage or abnormalities.The outer cone of the inlay, which is used to fix the inlay in the cup, shows a rather irregular wear pattern.Due to the circumstance that the provided inlay has already been tried to be anchored in the cup and due to the thermal processing probably carried out as a result of decontamination, it can be assumed that the dimensions no longer correspond to those on delivery.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 two similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) 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
Involved component: 9610612-2021-00104 (b)(4).Upon investigation, it was determined that the article reported under the mdr number 9610612-2021-00104 (b)(4) was a involved component.This is not causal for the error pattern.All information about this case is reported in this mdr.

• Brand Name: VITELENE INSERT E 32MM POST.WALL
• Common Device Name: HIP ENDOPROSTHESES - ACETABULA
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11388498
• Report Number: 9610612-2021-00158
• Device Sequence Number: 3866009
• Product Code: OQG
• UDI-Device Identifier: 04046963973872
• UDI-Public: 4046963973872
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 04/01/2025
• Device Model Number: NV301E
• Device Catalogue Number: NV301E
• Device Lot Number: 52605816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention