MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTL ALUM CER 28MM HD 12/14 +0; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	71332800
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during total hip arthroplasty, it was l found that the lot of product and the lot of package was different, and hospital refused to use.A delay greater than two hours was reported.No more information available yet.
Additional Manufacturer Narrative
The associated complaint device and packaging was returned and evaluated.A visual inspection of the returned ceramic head indicated some inner markings suggesting attempted use.A review of batch records indicated that the reference info on the device does match the batch info on the box and chart sticks.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part did not reveal additional complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: INTL ALUM CER 28MM HD 12/14 +0
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8616007
• Report Number: 1020279-2019-01951
• Device Sequence Number: 11518322
• Product Code: LZO
• UDI-Device Identifier: 03596010385338
• UDI-Public: 03596010385338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2019

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 Catalogue Number: 71332800
• Device Lot Number: 17MM03534D
• Initial Date Received by Manufacturer: 04/21/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 52