MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 12/14 28MM M; HIP ENDOPROSTHESES - HEADS

Model Number	NK461
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a biolox prosthesis head 12/14 28mm (part # nk461) was implanted during an unknown procedure performed on (b)(6) 2002.According to the complainant, eighteen (18) years post surgery, the ceramic head was damaged.The patient underwent a revision surgery on (b)(6) 2021.The complaint device was available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision surgery.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components: nk712t bicontact sd plasmapore 12/14 size 12mm - lot unknown.Nh048t.Plasmacup sc size 48mm.Lot unknown.Nh092 sc/msc ceramics insert 28mm 48/50 sym.Lot unknown.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM M
• Common Device Name: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11520498
• Report Number: 9610612-2021-00188
• Device Sequence Number: 11682142
• Product Code: LWJ
• UDI-Device Identifier: 04038653119882
• UDI-Public: 4038653119882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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 Model Number: NK461
• Device Catalogue Number: NK461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NH048T - LOT UNKNOWN; NH092 - LOT UNKNOWN; NK712T - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention