MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71302604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.Bipolar head and inner head were removed and antibiotic-loaded cement was placed.Stem was remained.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was communicated that due to infection, the head and bipolar component were removed and replaced with an antibiotic spacer while the stem remained in situ.No further clinically relevant documentation and/or information were provided, therefore the root cause of the reported infection remains unknown.The patient impact beyond the revision and probable additional antibiotic therapy and future revision procedure cannot be determined.No further medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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.We consider this investigation closed.Credit cannot be issued for these devices.

• Brand Name: COCR 12/14 FEM HD 26 + 4
• 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: 7908669
• Report Number: 1020279-2018-01844
• Device Sequence Number: 19317047
• Product Code: LPH
• UDI-Device Identifier: 03596010194084
• UDI-Public: 03596010194084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2019

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: Health Professional
• Device Catalogue Number: 71302604
• Device Lot Number: 17AM11437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 03/24/2019
• 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: Hospitalization
• Patient Age: 71 YR