MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X 62-64 20DG SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742862
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that intraoperatively, following implantation of acetabular cup, the surgeon was experiencing difficulties to lock the liner into the acetabular cup.Due to this surgeon subsequently explanted the acetabular cup, implanted a back-up cup and used a back-up liner to successfully complete the procedure, leading to surgical delay.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: REF LNR 28X 62-64 20DG SZ H
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6593548
• Report Number: 1020279-2017-00370
• Device Sequence Number: 1278837
• Product Code: LPH
• UDI-Device Identifier: 03596010232298
• UDI-Public: 03596010232298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K932755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2017

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 Expiration Date: 10/22/2022
• Device Catalogue Number: 71742862
• Device Lot Number: 12KM14629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided; 05/27/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 05/29/2017; 09/28/2017
• 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
• Patient Age: 59 YR