MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 12/14 28MM S; HIP ENDOPROSTHETICS

Model Number NK460

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product nk460 - biolox prosthesis head 12/14 28mm s.According to the complaint description, a postoperative fracture of the ceramic ball head occurred approximately eighteen (18) years after the initial implantation in 2005.The patient had made a step, slipped and fell.There was a "cracking" noise in the left hip, and pain in the groin.A revision was required.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Additional information was not provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4) ((b)(4)).Involved components: nh092/ sc/msc ceramics insert 28mm 48/50 sym.- lot unknown (internal aesculap ag ref.No.(b)(4)).Unknown hip stems bicontact - lot unknown (internal aesculap ag ref.No.(b)(4)).

Manufacturer Narrative

Additional information: h3 - evaluation, yes.H6 - codes updated.Investigation results: aesculap ag received six large and five small fragments of a ceramic femoral head as well as an unbroken ceramic insert.The components were forwarded to the manufacturer of the ceramic components, ceramtec gmbh, and examined as well as tested.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.The batch number is unknown, but the manufacturer has found the following possible orders with reference numbers: (b)(4).An applicable search was carried out for this.The quality documents show that for each of the three possibilities identified based on the data obtained for the femoral head, the product conformed to the specification valid at the time of manufacture.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Conclusion/preventive measures: extract from the investigation report of the manufacturer ceramtec: "in light of both components having met specifications at the time of delivery, considering the absence of a clear root cause emanating from our analysis and considering further the extreme longevity of the combination, the reported fall of the patient appears to have been a possible strong influencing factor with regard to the fracture of the ceramic femoral head." based upon the investigation results, a capa is not required.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18650698
• MDR Text Key: 334653876
• Report Number: 9610612-2024-00002
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: NH092 - LOT UNKNOWN; UNKNOWN HIP STEMS BICONTACT - LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male