MAUDE Adverse Event Report: AESCULAP AG SC/MSC CERAMICS INSERT 32MM 52/54 SYM.; HIP ENDOPROSTHETICS

Model Number NH103

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2020

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 nh103 - sc/msc ceramics insert 32mm 52/54 sym.The original implant date was on (b)(6) 2009.When the patient was getting into the car, there was a sudden painless cracking sound in the area of the left hip.Subsequently, increasing pain, especially during movement and stress.Presentation in the emergency room on (b)(6) 2020: evidence of an inlay fracture of the left hip tep.The revision occurred on (b)(6) 2020.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Involved components: nk561-biolox prosthesis head 12/14 32mm m.

Manufacturer Narrative

The complaint product was received on 2020-11-03 and was therefore available for investigation.The product evaluation was performed at the contract manufacturer and revealed the following: insert density the density was determined on the fragments of the insert.The measured density complies with the delivery specification for biolox®forte components ( >- 3.96 g/cm3).Reconstruction the ceramic insert cannot be reconstructed from the delivered fragments.There is only about 35% of the insert available.There are fragments missing, which could potentially yield further information if they were available.Therefore, the analysis of the fragments and the fracture surfaces remains technically incomplete.Metal transfer metal transfer of erratic appearance can be found on the outer surface, on the inner sphere and on the fracture surfaces of the insert.This secondary metal transfer was probably produced by chafing between metal parts and/ or surgical instruments and the fragments of the ceramic insert after the primary fracture event.Thus, it does not provide any information about the cause of the fracture.In case of a symmetrical taper fit between the ceramic insert and the metal cup, metal transfer patterns (primary metal transfer) are expected over the whole circumference in region g/h of the insert.The expected primary metal transfer cannot be found on the insert.However, due to the high amount of missing fragments from the taper region, the primary metal transfer cannot be evaluated comprehensively.Fracture surfaces obviously, fragments were chafing against each other in the period between the primary failure event and the delivery of the fragments to ceramtec.Due to this mechanism, intensive chipping occurred at fracture surface edges and on the fracture surfaces.Therefore, further information probably was lost which may have been helpful in the failure analysis.Ball head reconstruction the ceramic ball head is not broken.Metal transfer metal transfer of erratic appearance can be found on outer chamfer and on the face of the ball head.This secondary metal transfer was potentially produced by chafing between metal parts and/ or surgical instruments and the ceramic parts during the surgery.Thus, it does not provide any information about the cause of the incident.In the case of a symmetrical taper fit between the ceramic ball head and the metal taper, thin concentric lines (primary metal transfer) are expected over the whole circumference in the region c.These primary metal transfer patterns can be found equally distributed on the conical bore surface.Abrasion and breakouts on the polished surface of the ball head an area of metal abrasion and small breakouts can be found.The occurrence of this metal transfer and breakouts is a consequence of recurring contacts with the metal cup and the fragments of the insert after the primary fracture event.The ball head does not provide any indication regarding a possible cause for the fracture of the insert.Batch history review the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.Conclusion and measures the density of the insert was analysed and found to comply with the delivery specification for biolox ® components.The microstructure as obtained from the quality documents of both components meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.Secondary metal transfer patterns can be found on the fragments of the insert and on the ball head as a result of contact with metal parts after the primary fracture event.Due to missing fragments from the taper region, the expected primary metal transfer of the insert cannot be evaluated comprehensively.Due to secondary damages and missing fragments the primary fracture surface and the region of the fracture origin cannot be found.Primary metal transfer can be found equally distributed on the conical bore surface of the ball head.Abrasion and small breakouts on the polished surface of the ball head indicate an intensive contact with the metal cup and the fragments of the broken insert.The ball head does not provide any indication regarding a possible cause for the fracture of the insert.Due to missing fragments and secondary damages, it cannot be drawn any conclusion regarding a possible cause for the fracture of the insert.On the basis of the available information as well as the investigation results a clear root cause conclusion cannot be drawn.There is no indication for material-,manufacturing- or design-related failure.Based upon the investigation reuslts there is no capa necessary.

• Brand Name: SC/MSC CERAMICS INSERT 32MM 52/54 SYM.
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10853868
• MDR Text Key: 216685365
• Report Number: 9610612-2020-00478
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: NH103
• Device Catalogue Number: NH103
• Device Lot Number: 51513854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NK561-UNKNOWN; NK561-UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR