MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 22 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71302200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, patient had a revision surgery for a right total hip replacement on (b)(6) 2020.Patient developed a post-operative wound infection with collection at distal end of incision site.Surgeon revised femoral head and dual mobility head of construct whilst performing debridement and washout of wound.No prosthesis retrieved as surgeon sent them for pathology.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation and conducted confirms this case reports a revision of the femoral head and dual mobility head of construct while performing a washout and debridement, due to a post-operative wound infection of the incision site.Per email correspondence, there is no further information available, as consent has not been granted for release of the patient¿s medical history and personal details.Therefore, the clinical root cause of the event cannot be thoroughly assessed.No further medical assessment can be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.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.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: COCR 12/14 FEM HEAD 22 + 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks rd. 1450; memphis TN 38116
• MDR Report Key: 11314299
• Report Number: 1020279-2021-01141
• Device Sequence Number: 14391326
• Product Code: LPH
• UDI-Device Identifier: 03596010194039
• UDI-Public: 03596010194039
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71302200
• Device Catalogue Number: 71302200
• Device Lot Number: 19HM20554
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/19/2021
• 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