MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Toxicity (2333); Injury (2348)
Date of Event	01/15/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a left hip revision was performed due to septic hip, and metallosis.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup, head, sleeve & stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head.Similar complaints have been identified for the cup, sleeve and stem and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and pre-cautions 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 reported increase in wbc, esr and crp and discolored periarticular fluid along with intra-operative findings of a copious seropurulent fluid within a pseudocapsule, metallosis along the trunnion may be consistent with a periarticular joint infection and metallosis.However, without the analysis of the explanted components, the root cause of the reported infection and metallosis cannot be concluded and it cannot be confirmed that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9183978
• Report Number: 3005975929-2019-00361
• Device Sequence Number: 19454505
• Product Code: NXT
• UDI-Device Identifier: 00885556071694
• UDI-Public: 00885556071694
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: No Information
• Device Expiration Date: 07/30/2013
• Device Model Number: 74122552
• Device Catalogue Number: 74122552
• Device Lot Number: 08GW18138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 05/08/2020
• 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: ACETABULAR CUP HAP SIZE 52/58 74122158/10AW25642; ANTHOLOGY SO POROUS SIZE 7 71356007/10AM01941; MODULAR SLEEVE -4MM 12/14 74222100/09BW21795
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR