MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 20MM; HIP SEMI-CONSTRAIN, UNCMENTED, METALPOLYMER, NONPOROUS, CALICUMPHOSPHATE

Catalog Number	71332520
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient positioned and hip dislocated.Liner and screws removed cup was loose.Removed cup reamed acetabulum and implanted a 52mm multihole cup and three screws.A constrained liner inserted and checked to be locked in the cup.Hip reduced using a 22mm stryker head.Hip stable.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation the associated r3 3hole acetabular shell, r3 acetabular liner, head screws and hole cover were not returned for evaluation.A review of complaint history on the listed parts revealed no additional complaints for this issue with the same batch number.Our investigation included a review of the manufacturing records which did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that based on the available information, the root cause of the ¿cup loosening¿ cannot be concluded.It is unknown if the post-primary surgery fall contributed to the ¿loosening¿ but that explanation cannot be excluded.Without the return of the actual product involved, our investigation is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: REF SPHER HEAD SCREW 20MM
• Common Device Name: HIP SEMI-CONSTRAIN, UNCMENTED, METALPOLYMER, NONPOROUS, CALICUMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7262495
• Report Number: 1020279-2018-00149
• Device Sequence Number: 1185746
• Product Code: MEH
• UDI-Device Identifier: 03596010460455
• UDI-Public: 03596010460455
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 71332520
• Device Lot Number: 16KB01558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/10/2018
• Supplement Report FDA Received Date: 04/17/2018
• 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
• Patient Weight: 150