MAUDE Adverse Event Report: AESCULAP AG SC/MSC PE-INSERT 32MM 52/54 SYM.; MPLANTS PLASMACUP

Model Number NH203

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The plasmacup was implanted at (b)(6) hospital and removed at (b)(6) hospital.The reason for doing this was that the patient was experiencing pain and noise in the hip.The liner was found to be loose and damaged upon removal.The patient has now had a new liner and head implanted which should resolve their symptoms.

Manufacturer Narrative

Investigation: the components have been analyzed visually and microscopically.A curvature can be seen.This indicates a recurrent lever-out situation from the ball head out of the pe-insert (luxations).On the opposite side, the edge of the insert is very thin-walled which may indicate an edge-loading situation.On the outer surface of the pe-insert (taper region), black staining can be found.Furthermore, several damages (scratches, abrasion) can be found at the pe-insert.There are no signs of third body wear at the gliding surface of the pe-insert.At the outer surface of the metal ball head, conspicuous metal abrasion can be found which originated most likely from a contact with the plasmacup metal shell.Batch history review: the device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication of a material failure or a manufacturing defect.No further complaints registered against the same lot number.Conclusion and root cause: the failure is most probably usage/patient related.Rational: on the basis of the investigation as well as the provided information, we assume that the failure is most probably usage related.It is possible that the implantation situation was inappropriate.As mentioned, we assume that it came to several luxations in combination with an edge-loading situation.These occurrences may have led to loosening of the pe-insert after a specific amount of time due to plastic defamations.No capa is necessary.

• Brand Name: SC/MSC PE-INSERT 32MM 52/54 SYM.
• Type of Device: MPLANTS PLASMACUP
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7740967
• MDR Text Key: 115763748
• Report Number: 9610612-2018-00302
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K042344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

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: NH203
• Device Catalogue Number: NH203
• Device Lot Number: 51925063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Distributor Facility Aware Date: 07/05/2018
• Device Age: 5 YR
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR