MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROST, HIP, SEMI-CONS, METAL/CERAM/POLY, CEMEN OR NON-POR, UNCEM

Model Number	71343612
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	07/09/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a 2 stage revision due infection.All the components were removed and an antibiotic impregnated prostalac spacer was used.The patient was re implanted with a full smith and nephew system on (b)(6) 2012.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the reported positive cultures for staphylococcus epidermis and reported tissue cultures showing abundant neutrophils associated with granulation tissue and number over 100 per hpf [high power field] as well as intraoperative findings of bone loss lateral to the acetabulum and disruption of the posterior femoral neck may be consistent with findings associated with infection and erosion.Findings of this sort are not associated with a mal-performance of the implant.The patient impact beyond the pain, revision and reported post-op infection, and expected transient post-op convalescence period cannot be determined.No further clinical 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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• Common Device Name: PROST, HIP, SEMI-CONS, METAL/CERAM/POLY, CEMEN OR NON-POR, UNCEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9634408
• Report Number: 1020279-2020-00397
• Device Sequence Number: 2667619
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2020

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 Expiration Date: 11/10/2020
• Device Model Number: 71343612
• Device Catalogue Number: 71343612
• Device Lot Number: 10KM10307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/19/2020
• 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
• Patient Age: 57 YR