MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/13/2015

Event Type  Injury  

Event Description

It was reported left hip revision was performed due to pain and other complications not specified.It was reported the cobalt levels were 156.3 ng/ml, chromium levels 37.0 ng/ml.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain and other complications not specified.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 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.The available medical documents were reviewed.It was reported left hip revision was performed due to pain and other complications.In addition, it was reported the cobalt levels were 156.3 ng/ml, chromium levels 37.0 ng/ml.However, the only documents provided were the metal ions, left hip primary operative report, and a revision report for the right hip.Without the left hip revision report, the explant, or the requested clinical information we are unable to perform a thorough clinical investigation.Therefore, the future impact to the patient cannot be determined.Should the revision report, the explant or pertinent clinical information be provided for the left hip, this complaint will be re-evaluated.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.

Event Description

It was reported that a right hip revision was performed on (b)(6) 2015 due to pain and elevated metal ion levels in blood.A blood analysis performed on (b)(6) 2015 showed that the cobalt levels were 156.3 ng/ml and the chromium levels were 37.0 ng/ml.During the revision surgery performed on (b)(6) 2015, a bhr resurfacing acetabular cup and bhr resurfacing head were explanted and replaced with a tha construct.The operative report available for the primary surgery performed on (b)(6) 2009 details a left hip surgical procedure conducted due to femoral acetabular impingement which progressed to a degenerative joint disease.At this time, no primary implantation records have been received in regards of the right bhr construct.

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamingtong spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia de santis ; scachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6439202
• MDR Text Key: 71015226
• Report Number: 3005975929-2017-00066
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74122154
• Device Lot Number: 08EW17228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2008
• 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: 74123148/FEMORAL HEAD 48MM/08HW18650 /; PN: 74123148 / LT: 08HW18650; RESURFACING FEMORAL HEAD 46MM, NO PART AND LOT
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male