MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 8/10 28MM L; HIP ENDOPROSTHETICS

Model Number	NJ133K
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/18/2021
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 isodur prosthesis head 8/10 28mm l (part # nj133k) was implanted during a primary total hip arthroplasty (tha) procedure performed on (b)(6) 2011.According to the complainant, the implant dislocated and the revision surgery was ten (10) years four (4) months post surgery.The patient was expected to undergo a revision procedure on (b)(6) 2021.The complaint device has not been returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components: na766t - plasmacup fixation screw, 6.5x16mm - lot 51726335; nc450t - plasmacup sc plasmapore-cap, size 50mm - lot 51738636; nh472 - sc/msc pe-insert, 28mm 48/50 asym.- lot 51491493.
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: 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 1(5)) according to din en iso (b)(4) 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.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.
Event or Problem Description
Involved components na766t - plasmacup fixation screw 6.5x16mm - lot 51726335 nc450t - plasmacup sc plasmapore-cap size 50mm - lot 51738636 nh472 - sc/msc pe-insert 28mm 48/50 asym.- lot 51491493.

• Brand Name: ISODUR PROSTHESIS HEAD 8/10 28MM L
• 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: 12940874
• Report Number: 9610612-2021-00780
• Device Sequence Number: 17348299
• Product Code: LWJ
• UDI-Device Identifier: 04038653117932
• UDI-Public: 4038653117932
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 05/01/2019
• Device Model Number: NJ133K
• Device Catalogue Number: NJ133K
• Device Lot Number: 51575875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2009
• 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: NA766T - LOT 51726335; NA766T - LOT 51726335; NC450T - LOT 51738636; NC450T - LOT 51738636; NH472 - LOT 51491493; NH472 - LOT 51491493
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown