MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fluid Discharge (2686)
Date of Event	04/01/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal mdl* it was reported that, 4 weeks after the left hip resurfacing primary surgery performed on (b)(6) 2008, the patient started having pain, redness, increasing erythema and an unspecified infection.The patient was brought semi-urgently to the operating room for irrigation, debridement, and cultures of the hip.No devices were explanted.The patient was awakened and brought to the recovery room in satisfactory condition.The patient's infection was treated with these procedures, as well as with the use of a course of antibiotics.
Additional Manufacturer Narrative
G3, h2, h3, and h6: it was reported that after a left hip resurfacing primary surgery, the patient started having pain, redness, increasing erythema and an unspecified infection.As of today, the implanted devices all of which were used in the treatment remain implanted and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the bhr head and cup.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were sterilized.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The pain, increasing erythema, and mild drainage may be consistent with the reported post-op infection; however, the root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.It cannot be concluded that the post-op infection is associated with a mal-performance of the implant.The patient impact beyond the irrigation and debridement and post-op convalescence period cannot be determined.Without further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated a2: patient information available.D10: add concomitants.H6: update codes.

• Brand Name: ACETLR CUP HAP 50MM W/ IMPTR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12250101
• Report Number: 3005975929-2021-00363
• Device Sequence Number: 4441276
• Product Code: NXT
• UDI-Device Identifier: 03596010502568
• UDI-Public: 3596010502568
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 08/28/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 078277
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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: RESURFACING FEMORAL HEAD 42MM/077834
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 40 YR