MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333324
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the reflection 50-52, the acetabular liner implant it could not lock with acetabular cup, the surgery was extended for approximately 1 hour.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual examination indicated notable damage to the splines and flange from the attempted implantation.A clinical analysis indicated that no clinical supporting documents have been provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional evaluation indicated that the returned liner had features that could not be measured accurately due to damage that appeared to be from implantation attempts.The features that could be measured were to print specification.A review of complaint history on the listed parts revealed no prior complaints for the listed part.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this complaint closed.

• Brand Name: REF XLPE 28 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7279475
• Report Number: 1020279-2018-00199
• Device Sequence Number: 19051783
• Product Code: LPH
• UDI-Device Identifier: 03596010455611
• UDI-Public: 03596010455611
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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 Catalogue Number: 71333324
• Device Lot Number: 17CM16042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2018
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown