MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COBALT CHROME FEMORAL HEAD GLOBAL TAPER 32MM O.D. +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71303208
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/02/2002
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please also reference 1020279-2011-00469 as it relates to a different event for this patient.
Event or Problem Description
It was reported the patient presented with several episodes of subluxation of her right hip, not true dislocation.The surgeon believed the skirt on the metal head was impinging and causing the subluxation.The patient underwent a right total hip replacement revision surgery.The head and liner were replaced and soft tissue anteriorly was also debrided.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical analysis indicates based on the newly submitted medical records, the likely cause of the ¿gross polyethylene wear¿ and the resultant wear disease is due to the edge loading on the liner from the vertically placed cup.It cannot be concluded how much cup position changed over the 9 prior years but placement at this angle could be a result of the patients ¿irregular acetabulum¿ it is unknown if this patient¿s waldenstrom macroglobulinemia and its unreported treatments contributed to the deterioration of her acetabulum.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.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.No further actions are being taken at this time.

• Brand Name: COBALT CHROME FEMORAL HEAD GLOBAL TAPER 32MM O.D. +8
• 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: 7245671
• Report Number: 1020279-2018-00127
• Device Sequence Number: 1028107
• Product Code: LPH
• UDI-Device Identifier: 03596010194206
• UDI-Public: 03596010194206
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 04/05/2011
• Device Catalogue Number: 71303208
• Device Lot Number: 01CM04221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REFLECTION HOLECOVER PART#71336500 LOT#01FM06604; REFLECTION LINER PART#71743250 LOT#60409009; REFLECTION SHELL PART#71330152 LOT#00506963A; SYNERGY HEAD PART#71306412 LOT#01CM12589A
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR