MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 20 ANT +4 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/08/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a right hip revision surgery due to motion limiting heterotopic bone formation and pain.The liner and femoral head were exchanged and the heterotopic bone was removed from the pelvis and femur.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, heterotopic bone growth is a known complication of surgical procedures, as well as the zero degrees anteversion, are contributing factors for the revision.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved and/or device information our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: REF XLPE 36 20 ANT +4 54-56 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: 7275354
• Report Number: 1020279-2018-00180
• Device Sequence Number: 135666
• Product Code: LPH
• UDI-Device Identifier: 03596010455871
• UDI-Public: 03596010455871
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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 Expiration Date: 08/27/2012
• Device Catalogue Number: 71333375
• Device Lot Number: 02HM00416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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; Required Intervention
• Patient Age: 47 YR