MAUDE Adverse Event Report: AESCULAP AG SC/MSC CERAMICS INSERT 28MM 44/46 SYM.; HIP ENDOPROSTHETICS

Model Number NH091

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with nh048t - plasmacup sc size 48mm.According to the complaint description, the surgeon noted that the ceramic insert may have been fractured.According to the surgeon, the fracture is not widely extended over the insert, it is most likely chipped off at its rim.The patient had an unusual sensation in the hip.At this point of time, there is no revision surgery scheduled.The surgeon recommended the revision surgery as soon as possible.A revision surgery is necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

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: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale: unfortunately, due to the lack of data and without the product, we cannot determine the exact cause of the mentioned deviation.According to the quality standard, a production defect and a material defect can be excluded with a high degree of probability.If further investigation is required, the product should be made available for examination.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.

Manufacturer Narrative

Correction/additional information: b1: malfunction added.B5: leading material was updated and involved component added; additional details added.B6: x-ray added.D1: 2, d4 - brand name, common device name, batch, expiration date added.D6: implant and explant dates added.D9: product not returned.D10: involved component added.H4: production date.H6: codes updated.After update of the leading material, the product was determined not be sold in usa and the complaint was re-assessed; it is no longer considered reportable to fda, no malfunction nor serious injury.Investigation report was previously submitted.

Event Description

Update: leading material was changed, and involved component added.It was reported that there was an issue with nh091 - sc/msc ceramics insert 28mm 44/46 sym.During a regular check-up, x-ray showed a substance that looked like broken pieces of ceramic, and there was also a gurgling sound, so revision surgery was performed.When the joint was opened, some soft tissues were discolored white, and other soft tissues were not black.Liner was damaged due to chipping with neck on back of left "foot".Involved component: nh046t/ plasmacup sc size 46mm - lot: 51590155.

• Brand Name: SC/MSC CERAMICS INSERT 28MM 44/46 SYM.
• 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: 16908320
• MDR Text Key: 314973276
• Report Number: 9610612-2023-00104
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: NH091
• Device Catalogue Number: NH091
• Device Lot Number: 51375678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2006
• 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: NH046T - LOT 51590155.
• Patient Outcome(s): Required Intervention