MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Material Disintegration (1177); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/23/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis; elevated cobalt and chromium levels; pseudotumor.

Manufacturer Narrative

Type of reportable event: serious injury.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to metallosis; elevated cobalt and chromium levels; pseudotumor.As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.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 due to metallosis, elevated cobalt and chromium levels and pseudotumor.During revision, the bhr cup and the bhr head were removed.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.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.The primary surgery was performed in (b)(6) 2009.The revision was done 7½ years later ((b)(6) 2017).The intra-operative report documented; cobalt level of 57.5 and a chromium level of 27.3 (no unit of measure was given).There was a report of an mri that ¿showed evidence of fluid in the anterior hip with thickening of the synovium consistent with synovitis and pseudotumour¿.Also in the revision report; ¿blackened synovium was encountered¿ and ¿evidence of a large metallosis-type cyst was noted on the anterior aspect of the acetabulum¿.Based on the available information, the clinical findings of elevated cobalt and chromium levels (no unit of measure provided), and the synovitis and pseudotumour, may be consistent with an adverse reaction to metal wear associated with metal on metal products, but the source cannot be confirmed.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: ACETLR CUP HAP 52MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 7675132
• MDR Text Key: 113584803
• Report Number: 3005975929-2018-00257
• 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,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 092561
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 46MM 74121146 LOT 089510; FEMORAL HEAD COMPONENT/ UNKNOWN LOT NUMBER; FEMORAL HEAD COMPONENT/ UNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR