MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122550

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

Patient Problem Metal Related Pathology (4530)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Reference number: case-(b)(4).

Event Description

It was reported that after a right bhr-tha construct was implanted on (b)(6) 2008, plaintiff experienced cyst fluid collection, abscess, swelling, erythema, possible infection, metallosis, pain and elevated cobalt and chromium ions.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During the surgery granulomatous changes, cloudy fluid, and synovitis were noted.Also, trunnion gnosis with black staining of the trunnion was noted.The whole bhr-tha construct was removed and replace with new components.Plaintiff outcome is unknown.

Manufacturer Narrative

It was reported that revision surgery was performed on the patients right hip.As of today, the devices used in treatment have been requested but have not become available.A review of the historical complaints data for the cup, head, modular sleeve and stem was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the head, modular sleeve or stem.Other similar complaints were identified for the cup, this will continue to be monitored.A search was also performed using part numbers, the reported failure modes, and description summary 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 for the devices.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that the product met manufacturing sterility requirements 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 for the cup and stem.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A risk management was not performed for the head as these devices have 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; no further escalation actions required.The available medical information was reviewed.The clinical information provided, of the extensive lobulated cystic structure with fluid collection, granulomatous tissue, cloudy fluid, synovitis, and trunnionosis with black staining of the trunnion may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without additional information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: HEMI HEAD 50MM
• 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: 12788659
• MDR Text Key: 280597765
• Report Number: 3005975929-2021-00525
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• 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: 05/17/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2012
• Device Catalogue Number: 74122550
• Device Lot Number: 07JW13574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2007
• 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: ACETLR CUP HAP 56MM W/ IMPTR; ANTHOLOGY SO POR PL HA SZ 7
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male