MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CAN ACET SCREW 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71336540
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after thr surgery, x-ray film results show that the screw is out of the outer cup.And during surgery, it wasn't found.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no conclusion to the root cause can be made based on the information provided and the product not being returned for analysis.Long-term impact is that at the current cup position the pt will be likely to experience dislocations.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: UNIV CAN ACET SCREW 40MM
• 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: 8681408
• Report Number: 1020279-2019-02241
• Device Sequence Number: 3020716
• Product Code: JDI
• UDI-Device Identifier: 03596010197696
• UDI-Public: 03596010197696
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 71336540
• Device Lot Number: 18MM05244
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/09/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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: Hospitalization; Required Intervention