MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28ID 20 DEG SZ F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742854
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a hip revision surgery, (b)(4) acetabulum cup and 54-56 liner were used, after the cup was implanted properly, the liner couldn't be implanted to the location, after several times trials, still failed.The patient condition was not well, so the surgeon had to choose cup+ bone cement to complete the surgery.The post-surgery outcome of the patient is being closely watched.
Additional Manufacturer Narrative
After further review, it was determined that this report was filed in error.Please disregard.If further information is obtained that changes this determination, the investigation will be re-opened.

• Brand Name: REF LNR 28ID 20 DEG SZ F
• 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: 6978119
• Report Number: 1020279-2017-00914
• Device Sequence Number: 1934424
• Product Code: LPH
• UDI-Device Identifier: 03596010232274
• UDI-Public: 03596010232274
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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: No Information
• Device Catalogue Number: 71742854
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 10/30/2017
• 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: Other
• Patient Age: 75 YR