MAUDE Adverse Event Report: AESCULAP AG SC/MSC PE-INSERT 28MM 56/58 SYM.; HIP ENDOPROSTHETICS

Model Number NH194

Device Problem Osseointegration Problem (3003)

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

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Investigation results: the complained product was not available for investigation.The investigation was based upon device history review and historical data analysis.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to the manufacturer's specifications, valid at the time of production.There are no other similar complaints within this batch.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 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.

Event Description

It was reported that there was an issue with the product nh194 - sc/msc pe-insert 28mm 56/58 sym.According to the complaint description, the patient with the cup implanted in 2014, had a dislocation.Therefore, a revision surgery was carried out on (b)(6) 2024.The implant was removed and a cement mold will be placed and revision surgery will be scheduled once again after the infection has subsided.Only one of the five screws in the plasma cup was broken, but all of them had fallen out and had fallen near the neck of the stem.The cup, along with the liner, could be removed by hand.One broken screw tip was left in place.It was assumed that the screw hole expanded and passed through the poly liner because it was attached to the cup.The stem was a non-aesculap cementless stem and the head was metal.Additional information was not provided nor available.The adverse event is filed under internal aesculap ag ref.No.(b)(4) ((b)(4) ).Associated medwatch-reports: 9610612-2024-00058 (internal aesculap ag ref.No.(b)(4) - nh158t).

• Brand Name: SC/MSC PE-INSERT 28MM 56/58 SYM.
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; JA 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: 18768935
• MDR Text Key: 336194147
• Report Number: 9610612-2024-00059
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042344
• 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
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: NH194
• Device Catalogue Number: NH194
• Device Lot Number: 51930024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2013
• 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
• Patient Outcome(s): Required Intervention