MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336500
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the device, compatible with an r3 cup, could not be screwed into the central thread of the r3 cup.An unspecified change in surgical technique was needed in order to complete the procedure.A delay of 30 min or less was reported.

• Brand Name: REF THREADED HOLE COVER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11166947
• Report Number: 1020279-2021-00351
• Device Sequence Number: 700827
• Product Code: MBL
• UDI-Device Identifier: 03596010197634
• UDI-Public: 03596010197634
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K070756
• 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): 09/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71336500
• Device Catalogue Number: 71336500
• Device Lot Number: 20JM02520
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 09/06/2021
• 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: Required Intervention