MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333); Test Result (2695)

Event Date 02/20/2019

Event Type  Injury  

Event Description

It was reported a left hip revision was performed due to severe pain in the left hip and elevated cobalt chrome levels, milky looking fluid and brownish/greenish debris.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup, modular sleeve and hemi head were removed.The anthology 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.A review of the complaint history for the cup, head, sleeve and stem 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 head, cup & stem.A similar complaint has been identified for the sleeve and this failure will continue to be monitored.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.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed.It cannot be determined to what extent the patients fall had on her pain and clinical status.The reported pain, increase in metal levels and intraoperative findings of milky looking fluid as well as brownish/greenish debris are findings consistent with metallosis; however, without the supporting lab/pathology results, imaging and/or the analysis of the explanted components the source of reactions 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.

• Brand Name: ACETLR CUP HAP 54MM 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 9383769
• MDR Text Key: 168229301
• Report Number: 3005975929-2019-00413
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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
• Report Date: 01/23/2020

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: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 090258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECH STEM 71927978/ 07MM06082.; HEMI HEAD 74122546/ 08GW18089.; MODULAR SLEEVE 74222100/ 08EW16959.; ECH STEM 71927978/ 07MM06082; HEMI HEAD 74122546/ 08GW18089; MODULAR SLEEVE 74222100/ 08EW16959
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR