MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 13; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71306113
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Test Result (2695); Patch Test, Abnormal Results Of (3166)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presents increased titanium level due to titanium is present in implanted components.Titanium level 3.64 (upper reference range per als (b)(4) ab is 2.96).
Additional Manufacturer Narrative
The affected titanium modular head sleeve, synergy femoral component and r3 0 hole acetabular shell were not returned for evaluation.A clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed at this time.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: SYN POR HO FEM COM SZ 13
• 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: 8039622
• Report Number: 1020279-2018-02373
• Device Sequence Number: 16469464
• Product Code: LPH
• UDI-Device Identifier: 03596010291974
• UDI-Public: 03596010291974
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: Lay User/Patient
• Device Expiration Date: 09/23/2021
• Device Catalogue Number: 71306113
• Device Lot Number: 11JM13471
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/18/2019
• 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