MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 8/10 28MM M; HIP ENDOPROSTHETICS

Model Number NJ102

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/11/2020

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 biolox prosthesis head.According to the customer description, it was reported that the patient, who received total hip arthroplasty (tha) in 2003, was diagnosed with suspected ceramic liner breakage.The patient has difficulties in walking.A cup revision is scheduled on (b)(6) 2020.Details have not yet been provided.Infection : unknown.A revision surgery was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2020-00195 ((b)(4) nj102); 9610612-2020-00196 ((b)(4) nh048t).

• Brand Name: BIOLOX PROSTHESIS HEAD 8/10 28MM M
• 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: nadine schweikart ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10130138
• MDR Text Key: 194554090
• Report Number: 9610612-2020-00002
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NJ102
• Device Catalogue Number: NJ102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: No
• 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