MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122544
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/11/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a left hip revision due to severe pain, severe instability, severe discover, pseudotumor formation, metallosis, adverse local tissue reaction, and limited mobility.
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 have been requested for this complaint but have not become available.A review of the complaint history for the hemi head, r3 liner, r3 shell, stem and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the hemi head, liner, acetabular shell and stem.Similar complaints have been identified for the modular sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 reopened.No preventative or corrective action has been initiated as a result of this investigation.
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 have been requested for this complaint but have not become available.The hemi head, sleeve and r3 liner, are no longer sold by smith & nephew.A review of the complaint history for the hemi head, r3 liner, r3 shell, stem and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the liner, shell and stem.Similar complaints have been identified for the hemi head and modular sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.The available medical documents were reviewed.It should be noted bhr contraindications include patients with known moderate to severe renal insufficiency and patients who are immunosuppressed with diseases such as aids or persons receiving high doses of corticosteroids.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the revision operative report indicated the acetabular component was in very little anteversion and about 55 degrees lateral opening.The elevated cobalt and chromium levels and the noted intraoperative findings of necrotic debris, corrosive materials and pseudotumor may be consistent with findings associated with metallosis; however, the root cause of the reported pain, elevated cobalt and chromium levels, adverse local tissue reaction, pseudotumor and metallosis cannot be confirmed, and it cannot be concluded that the reported reactions were associated with a malperformance of the implant.It was reported the patient died 6/8/18, the reported cause of death is not related to a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.However, the probable root cause is improper loading due to the acetabular cup position noted in the revision operative report.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 44MM
• 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: 9384303
• Report Number: 3005975929-2019-00418
• Device Sequence Number: 16684042
• Product Code: NXT
• UDI-Device Identifier: 00885556070994
• UDI-Public: 00885556070994
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

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: Lay User/Patient
• Device Expiration Date: 01/29/2014
• Device Model Number: 74122544
• Device Catalogue Number: 74122544
• Device Lot Number: 09AW21513
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 06/25/2020; 08/21/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 06/29/2020; 08/21/2020
• 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: ACET SHELL 71331856/ 10DM06048; COCR LNR 71341156/ 09AW21624; ECH STEM 71341024/ 10AM02357; MODULAR SLEEVE 74222100/ 09BW21793; ACET SHELL 71331856/ 10DM06048; COCR LNR 71341156/ 09AW21624; ECH STEM 71341024/ 10AM02357; MODULAR SLEEVE 74222100/ 09BW21793
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention