MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CAN ACET SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71336525
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the r3 acetabular cup was implanted, it was fixed with a 25mm screw.Postoperative x-ray shows that the screw fell out of the acetabular cup.
Additional Manufacturer Narrative
The associated acetabular universal cancellous screw was not made available for evaluation.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.As the device was not returned for analysis, a dimensional evaluation could not be performed.A clinical analysis noted that one undated x-ray was provided which showed the screw is through the shell but can¿t conclude any migration of the shell.However no medical documents have been forthcoming.It has been communicated that the patient has had no adverse effects at this time; and no plans for removal of the screw have been made.Based on the limited information available, the root cause of the screw, ¿falling out¿ or what appears to be slipping through cannot be concluded.The screw is an implantable component so biocompatibility is not an issue.However micro-motion or movement of the screw cannot be predicted.Follow-up information regarding this patient¿s status has not been provided.This issue has been communicated to our product development team for consideration.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIV CAN ACET SCREW 25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8062773
• Report Number: 1020279-2018-02435
• Device Sequence Number: 14097106
• Product Code: JDI
• UDI-Device Identifier: 03596010197665
• UDI-Public: 03596010197665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K920430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71336525
• Device Lot Number: 17MB00493
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR