MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122548

Device Problem Biocompatibility (2886)

Patient Problems Osteolysis (2377); Metal Related Pathology (4530)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, after primary left hip bhr resurfacing surgery was performed on (b)(6) 2009, the patient experienced pain and subluxation of the femoral component, for which revision surgery was conducted on (b)(6) 2012 (covered under (b)(4)).Subsequently, the patient experienced cobalt and chromium toxicity, as well as acetabular osteolysis.This adverse event was treated with revision surgery on (b)(6) 2020.From all the components, only the stem was left in place.The system was replaced to a competitor´s tha.The patient tolerated the procedure well.

Manufacturer Narrative

It was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have been requested for this complaint but have not become available.A review of the historical complaints data for the acetabular cup and the hemi head and sleeve 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.No other similar complaints were identified to involve this batch for the acetabular cup and hemi head.Other similar complaints were identified to involve this batch for the sleeve.However, as the device is no longer sold, no action is to be taken.No other similar complaint has been identified for the part number and the reported failure mode for the sleeve.Other similar complaints have been identified for the part number and the reported failure mode for the acetabular cup and hemi head.However, hemi heads, sleeves are no longer sold, no action is to be taken.This failure will continue to be monitored for the acetabular cup.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 upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified for the acetabular cup.Prior applicable escalation actions were identified for the hemi head and sleeve and confirmed to reduce associated risks as far as possible; no further escalation actions required.The available medical documents were reviewed.Heterotopic ossification is a known complication of joint surgeries and is related to the procedure.The revision operative report did not note any findings of metallosis.The ¿grossly loose¿ acetabular component and cavitary defects of the acetabulum noted intraoperatively are consistent with findings associated with osteolysis.However, based on the information provided, the clinical root cause cannot be confirmed.Although it was reported the patient experienced chromium toxicity, neither the levels nor laboratory reports were provided for review.Without the supporting laboratory/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported events and intraoperative findings cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the revision cannot be determined.Based on the information provided, we can confirm this complaint.Heterotopic ossification is a known complication of joint surgeries and a possible root cause in addition to the noted osteolysis and loose acetabular component.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, excessive patient weight, trauma to the joint replacement.Should the devices or additional information be received, the complaint will be reopened.Based on the investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: HEMI HEAD 48MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 14436195
• MDR Text Key: 292030452
• Report Number: 3005975929-2022-00273
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071847
• UDI-Public: 885556071847
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2014
• Device Catalogue Number: 74122548
• Device Lot Number: 09AW21004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP HAP SIZE 48/54; MODULAR SLEEVE -4MM 12/14; SYN POR FEM COMP SZ 15
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male