MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DM XLPE INSERT 22/40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71358216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha surgery, the patient's wound was not clearing up.The patient had a washout and an insert exchange.The patient outcome is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per complaint details, a revision consisting of a ¿washout¿ and liner exchange was performed approximately 1 month post implantation due to the wound not clearing in an obese patient.It was communicated that operative reports/requested medical documentation would not be provided for inclusion in the medical investigation.Reportedly, the surgeon did not fault the components.Although statistically, obese patients have a higher risk for post-operative infections, the root cause of the infection could not be concluded based on the information provided.The patient impact beyond the reported events could not be determined.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OR3O DM XLPE INSERT 22/40
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10681479
• Report Number: 1020279-2020-05398
• Device Sequence Number: 14193468
• Product Code: LPH
• UDI-Device Identifier: 00885556712351
• UDI-Public: 00885556712351
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K191002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2021

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: 09/05/2026
• Device Model Number: 71358216
• Device Catalogue Number: 71358216
• Device Lot Number: A1918932
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 08/21/2021
• 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: 71342208, LOT: 15JM16915
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 110