MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122542

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Us legal mdl.It was reported that, after a left bhr tha constructs had been implanted on (b)(6) 2010 as a part of a first revision surgery, the plaintiff experienced mechanical complications and cobalt and chromium toxicity.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.There was some metallosis found at the trunnion.There was some osteolysis found in the acetabulum.The metal femoral head was revised to a dual mobility poly insert with an oxinium femoral head.The cup and the stem were not explanted.

Manufacturer Narrative

H3, h6: it was reported that a second left hip revision surgery was performed.During the revision, the hemi-head was explanted.The cup and the stem remained implanted.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.Without definitive part/lot numbers a review of the historical complaints data for the acetabular cup cannot be performed.A review of the historical complaints data for the hemi 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 of 12 months prior to the date in which the incident was reported.A similar complaint was identified to involve this batch.A similar complaint has been identified for the part number and the reported failure mode in this timeframe.However, as the device is no longer sold, no action is to be taken.A review of the historical complaints data for the spout 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 of 12 months prior to the date in which the incident was reported.No other similar complaints were identified to involve this batch.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.A review of the historical complaints data for the stem 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 of 12 months prior to the date in which the incident was reported.No other similar complaints were identified to involve this batch.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.A review of the historical complaints data for the modular 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 of 12 months prior to the date in which the incident was reported.Other similar complaints were identified to involve this batch, two of which relate to the same patient.However, as the device is no longer sold, no action is to be taken.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.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 manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.A non-conformance was identified for the machining paperwork for the hemi-head.However, all supporting documents confirm that this was an acceptable product when released.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.The available medical documents were reviewed.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion.However, the revision operative report indicated the acetabular component was positioned at about 25 degrees of anteversion.It is unknown if the increased anteversion led to accelerated wear and the reported cobalt and chromium toxicity and the intraoperative findings of metallosis and osteolysis.With the information provided, the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded that the reported clinical reactions/events were associated with a mal performance of the implant or implant failure.The patient impact beyond the revision and expected transient post-operative convalescence period cannot be determined.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.

• Brand Name: HEMI HEAD 42MM
• 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: 12344383
• MDR Text Key: 267335782
• Report Number: 3005975929-2021-00379
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556070710
• UDI-Public: 885556070710
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2014
• Device Catalogue Number: 74122542
• Device Lot Number: 09DW08850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female