MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71331856
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Initial reporter postal code (b)(6).
Event or Problem Description
It was reported that, during a thr surgery, after several attempts it was not possible insert a r3 0 deg xlpe acet lnr 32mm x 56mm and a r3 0 deg xlpe acet lnr 36mm x mm56.Surgery was resumed, after a non-significant delay, removing the r3 0 hole acet shell 56mm and replacing it with a r3 cup with 3 holes, a new 56/32 inlay could only be inserted with difficulty.Patient was not injured as consequence of this problem.

• Brand Name: R3 0 HOLE ACET SHELL 56MM
• 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: 12729734
• Report Number: 1020279-2021-07747
• Device Sequence Number: 1558550
• Product Code: MBL
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71331856
• Device Catalogue Number: 71331856
• Device Lot Number: 21FM00241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR