MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS HIP STEMS EXCIA; HIP ENDOPROSTHETICS

Model Number AE-QAS-H546-34

Device Problem Fracture (1260)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

Patient year of birth: (b)(6).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 a postoperative issue with a hip stem.The primary implantation occurred in 2005, total hip left "in domo".The patient also had undergone right total hip "in domo" in 2004.On (b)(6) 2018, the patient felt pain in the area of the left hip and was admitted to the hospital.A fall onto the hip had not occurred, however, the patient had fallen forward a month before and dislocated the right shoulder.A revision procedure was planned due to cone fracture of the stem.It was noted that the patient had been mobile without walking aids and lived alone prior to the implant breakage.Details about the revision were not provided.

Manufacturer Narrative

Manufacturing site evaluation: there were no devices available for investigation.No pictures were provided.Batch history review: due to the circumstance that the lot number is not available, we checked all lot numbers from products delivered to the facility in the years 2004 and 2005.The device quality and manufacturing history records have been checked for all lot numbers and found to be according to our specifications valid at the time of production.There is only one similar complaint with lot 51067880.Conclusion and root cause: based on the information available it is not possible to determine a root cause for the failure.It could be possible that the failure is patient/usage related.Rationale: in light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a root cause for the mentioned failure.At that time we exclude a design-related error because the market feedback is unremarkable on this matter.It could be possible that the breakage resulted due to an overload situation.Furthermore, it could be possible that tiniest damages on the stem neck (from for example instruments) may also have led to a supporting fracture situation.A capa is not necessary.

• Brand Name: COLLECT.NO.QAS HIP STEMS EXCIA
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8874360
• MDR Text Key: 153689606
• Report Number: 9610612-2019-00535
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-H546-34
• Device Catalogue Number: AE-QAS-H546-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention