MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122546

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Injury (2348)

Event Date 12/27/2016

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metal on metal soft tissue destruction with metallic debris, severe pain, discomfort, inflammation around the hip implant, elevated blood metal ion levels and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr cup and synergy stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.The reported pain and the intraoperative findings of pseudotumor, metal on metal soft tissue destruction with metallic debris, crescentic fluid collection are consistent with findings associated with metallosis; however, without the supporting pathology, imaging, and/or the analysis of the explanted components, the root cause cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with 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, 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.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The bhr cup and stem remained implanted.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 bhr cup, hemi head 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 bhr cup.Similar complaints have been identified for the hemi head and 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 known 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 and no further actions are required at this time.The available medical documents were reviewed.The reported pain and the intraoperative findings of pseudotumor, metal on metal soft tissue destruction with metallic debris and crescentic fluid collection are consistent with findings associated with metallosis.However, without the supporting pathology, imaging, and/or the analysis of the explanted components, the root cause cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.

• Brand Name: HEMI HEAD 46MM
• Type of Device: 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: 8060620
• MDR Text Key: 126890383
• Report Number: 3005975929-2018-00435
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08GW18084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 10/30/2018; 08/06/2020
• Supplement Dates FDA Received: 11/15/2019; 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306115/ SYN POR HO FEM SZ 15/ 08MM16112; 74120152/ ACETLR CUP HAP 52MM/ 086163; 74222200/ MOD SLEEVE PLUS 0MM 12/14/ 08FW17509; UNKNOWN BHR DEVICE/UNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR