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

Model Number NK460

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/06/2023

Event Type  Injury  

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, the patient fell and felt pain in the right hip joint after that.A revision surgery was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference 100033442 (400609457).Involved components nh094 - sc/msc ceramics insert 28mm 56/58 sym.- lot 51027393 nh056t - plasmacup sc size 56mm - lot 51071887 nk724t - bicontact plasmapore 12/14 size 14mm - lot 51077397.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: b2 - outcome updated h3 - product evaluation h6 - codes updated investigation results: the components have been forwarded to the manufacturer of the ceramic components.Fragments were examined by the manufacturer.The femoral head was broken.Three large and three small fragments of a ceramic femoral head were submitted.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.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable according to procedures; severity was 4(5) and probability 1(5).Conclusion and preventive measures: extract from the investigation report of the manufacturer ceramtec: "in the absence of a clear root cause emanating from our analysis and considering the extreme longevity of the combination, the reported fall of the patient appears to be a possible strong influencing factor with regard to the fracture of the ceramic femoral head." based upon the investigation results, a capa is not necessary.

Event Description

Involved components nh094 - sc/msc ceramics insert 28mm 56/58 sym.- lot 51027393 nh056t - plasmacup sc size 56mm - lot 51071887 nk724t - bicontact plasmapore 12/14 size 14mm - lot 51077397.

• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17627745
• MDR Text Key: 322020011
• Report Number: 9610612-2023-00197
• 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: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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
• Device Lot Number: 51066444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2005
• 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: NH056T - LOT 51071887; NH056T - LOT 51071887; NH094 - LOT 51027393; NH094 - LOT 51027393; NK724T - LOT 51077397; NK724T - LOT 51077397
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female