MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120148
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Metal Related Pathology (4530)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right birmingham hip resurfacing had been performed on (b)(6) 2011, plaintiff has experienced hip pain.A revision surgery was performed on (b)(6) 2021 and it was converted to a tha.During the surgery it was found metallosis and it was done a resorption of the femoral neck.Patient outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that right hip revision surgery was performed.During the revision, both the cup and the head were explanted.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.Since part/lot details were not received for investigation no thorough manufacturing record review or assessment of the reported event can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain and metallosis) were associated with a mal performance of the implant.The patient impact cannot be determined at this time.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Event or Problem Description
It was reported that, after a right bhr on (b)(6) 2011 due to osteoarthritis.The plaintiff has experienced pain and metallosis.Plaintiff underwent revision surgery on (b)(6), 2021 where a fractured of the proximal femur because of previous damage of his femoral neck from metallosis occurred.During surgery, metallosis was confirmed with staining of the tissues around the joint compatible with a pseudotumor.The patient's condition is unknown.
Additional Manufacturer Narrative
Sections b4, d4 and h4 were updated due to new information received.
Additional Manufacturer Narrative
H10: additional information in b5 and h6 (updated code e and f).H3, h6.It was reported that a right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the acetabular cup and femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and for the part number and the reported failure mode.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.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The =46mm bhr resurfacing system has been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; it was confirmed that the listed batch was manufactured before corrective action implementation.No further escalation actions required.The available medical documents were reviewed.Although a metal ion level above 14 parts per billion, radiographs showing resorption of the proximal femur, and pathology showing macrophage laden tissue were reported; neither lab, radiology nor pathology reports were provided.The elevated metal ion, resorption of the proximal femur with subsequent fracture and intraoperative findings of stained and macrophage laden tissue may be consistent with the reported ¿metallosis and pseudotumor.¿ however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of reactions cannot be confirmed, and it cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12778570
• Report Number: 3005975929-2021-00508
• Device Sequence Number: 3459406
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 3596010502551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2022

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 Expiration Date: 07/29/2013
• Device Catalogue Number: 74120148
• Device Lot Number: 090690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/03/2022; 04/01/2022; 05/20/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/03/2022; 04/20/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female