MAUDE Adverse Event Report: AESCULAP AG BIOLOX DELTA PROSTHESIS HEAD 8/10 32MM L; HIP ENDOPROSTHETICS

Model Number NJ108D

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Joint Dislocation (2374)

Event Date 11/25/2019

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 delta prosthesis head.It was reported that the patient had primary surgery in (b)(6) 2001.Later in (b)(6) 2019, she had first revision surgery due to wear of the implants, the detail is unknown.On (b)(6) the patient had dislocation of the hip prosthesis.X-ray examination revealed migration of the acetabular cup.Second revision will be conducted in december.Not known if the sample will be available or not.A revision surgery was necessary.An additional medical intervention was necessary.Additional information was requested.The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00832 ((b)(4) nv305e).9610612-2019-00833.9610612-2019-00834 ((b)(4) nv010t).

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about a gc587r - saw bl.F/gb128r 7/11/0.4/0.6/shk.105mm regarding an intraoperative breakage.We did receive the saw blade for investigation in a decontaminated condition.Investigation: the product was investigated visually and microscopically.It can be confirmed that the saw blade broke off directly at the shaft.The laser welding seam does not show any abnormalities.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.At the edges on the saw blade fragment, slight bent tongues can be found directly on the breakage points.Conclusion and root cause: the failure is most probably usage related.Rationale: after the investigation, we suspect that the breakage is most probably usage related due to an overload situation.The bent tongues on edges of the saw blade fragment indicate that it came to higher forces which may have led to the breakage.There are no hints for a material or manufacturing failure.Furthermore, based on the market surveillance and the statistical analysis, there is no indication for a systematic failure.Corrective action according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

Manufacturer Narrative

Associated medwatch report: 9610612-2019-00841 (400454894 nv305e) 9610612-2019-00840 (400454897 nv010t).Investigation results: we did not receive any devices/explants for investigation.The following information was provided by the subsidiary: 1 month post operative acetabular cup migration.The patient(82yrs female) had primary surgery in (b)(6) 2001.Later in (b)(6) 2019, she had first revision surgery due to wear of the implants (detail unknown ) 25th nov.The patient had dislocation of the hip prosthesis.X-ray examination revealed migration of the acetabular cup.No product at hand, therefore a failure description is not possible.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure.We assume that the failure is not product related.It could be possible that the failure is usage/patient related.Rational: there are no hints for a material problem.As described in mail correspondence:" this is all about technical error and was not related to products.A further root cause could be an inadequate bone quality of the patient.A capa is not necessary.

• Brand Name: BIOLOX DELTA PROSTHESIS HEAD 8/10 32MM L
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9439974
• MDR Text Key: 170087557
• Report Number: 9610612-2019-00839
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K082991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NJ108D
• Device Catalogue Number: NJ108D
• Device Lot Number: 52511491
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR