MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 12/14 32MM S; HIP ENDOPROSTHETICS

Model Number NK560

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/02/2023

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 nk560 - biolox prosthesis head 12/14 32mm s.According to the complaint description, the patient had pain in the right hip joint for 12 weeks.The radiological investigation confirmed a fracture of the ceramic head.This event occured 12 years after the total endoprothese implantation.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference: (b)(4).Involved components: nh054t - plasmacup sc size 54mm - lot: 51691991.Nh103 - sc/msc ceramics insert 32mm 52/54 sym.- lot: 51748258.Nk512t - bicontact s plasmapore 12/14 size 12mm - lot: 51778845.

Event Description

Involved components: nh054t - plasmacup sc size 54mm - lot 51691991, nh103 - sc/msc ceramics insert 32mm 52/54 sym.- lot 51748258, nk512t - bicontact s plasmapore 12/14 size 12mm - lot 51778845.

Manufacturer Narrative

Additional information: h3 - evaluation.H4 - production date.H6 - codes updated.Investigation: an unbroken ceramic femoral head and a metal cup were submitted.They have been forwarded to the manufacturer of the ceramic components (ceramtec gmbh, plochingen), where they were examined.Batch history review: the device quality and manufacturing history records (dhr) 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 0 similar complaints against the same lot number the current failure rate is within the risk analysis and therefore acceptable according to din en iso 14971; severity was 4(5) and probability 1(5).Explanation and rationale: the microstructure obtained from quality documents of both components meets requirements specificed at the time of production.There is no indication of any pre-existing material defect.Due to the fact that the insert was not provided for analysis, no conclusion can be drawn regarding a possible cause for the fracture of the insert.Both components showed abrasion which indicated intensive contact between parts after the primary fracture event.Conclusion and preventive measures: based upon the investigation results, a clear root cause cannot be determined.The femoral head does not provide any indication regarding a possible cause for the failure, and neither does the metal cup.Based upon the investigation results, a capa is not necessary.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 32MM 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: 17309773
• MDR Text Key: 319007492
• Report Number: 9610612-2023-00166
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK560
• Device Catalogue Number: NK560
• Device Lot Number: 51775846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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: NH054T - LOT 51691991; NH054T - LOT 51691991; NH103 - LOT 51748258; NH103 - LOT 51748258; NK512T - LOT LOT 51778845; NK512T - LOT LOT 51778845
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male