MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357009
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to an infection.The whole system was explanted and a new s&n system was implanted.
Additional Manufacturer Narrative
The associated complaint devices, used in treatment, were not returned and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The root cause of the revision approximately 3 weeks post implantation was reportedly an infection, and not a failure of the implants.The patient impact beyond the reported infection and subsequent revision could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Infection is a potential complication associated with any surgery.Some potential probable causes could include but are not limited to contamination, patient reaction, and a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: ANTHOLOGY SO POR PL HA SZ 9
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9070332
• Report Number: 1020279-2019-03381
• Device Sequence Number: 3042226
• Product Code: JDI
• UDI-Device Identifier: 03596010559524
• UDI-Public: 03596010559524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 Model Number: 71357009
• Device Catalogue Number: 71357009
• Initial Date Received by Manufacturer: 08/25/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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