MAUDE Adverse Event Report: AESCULAP AG BIPOLAR CUP ID26MM OD49MM SELF-CENTERING; HIP ENDOPROSTHETICS

Model Number NK299K

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a bipolar cup id26mm od49mm self-centering (part # nk299k) was used during a procedure performed on (b)(6) 2021.According to the complainant, an artificial head replacement was performed on an elderly patient with dementia, and a few days later, the head dislocated from the cup.At the time of discovery, the patient had an excessively external hip joint.The patient underwent a revision procedure on (b)(6) 2021 where the head and the cup were replaced.At that time, it was confirmed that the lock ring of the cup had not come off.The complaint device was returned to the manufacturer for evaluation.The patient underwent a revision procedure.The patient has no infection.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: slight damages (scratches, imprints) can be found on the front surface of the bipolar cup and on the pe safety ring.The products were investigated visually and microscopically.In general, the components are in condition as expected after an implantation time.Several scratches can be found at the outer surface of the bipolar shell.Additionally slight scratches and imprints can be found at the front face of the bipolar cup.The secondary damages mentioned above occurred most likely during the revision surgery.A conspicuous dent can be found at the inner diameter of the safety ring.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 our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.Based upon the investigations results a capa is not necessary.

• Brand Name: BIPOLAR CUP ID26MM OD49MM SELF-CENTERING
• 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: 12783258
• MDR Text Key: 280571886
• Report Number: 9610612-2021-00700
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK299K
• Device Catalogue Number: NK299K
• Device Lot Number: 52659274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 46 KG