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 Pitted (1460); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 09/30/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to pain and elevated serum ion levels.Cup implanted during original 2007 resurfacing.

Manufacturer Narrative

It was reported that a second hip revision surgery was performed.During the revision, the bhr cup, hemi head and sleeve were removed.The 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 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 and hemi head.Similar complaints have 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.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 a result of the reported event.The available medical documents were reviewed.Although it was reported that the metal ion levels were elevated, no levels were provided, and it was reported a preoperative workup for infection was negative.The reported pain, elevated metal ions along with intraoperative findings of black corrosion noted on the trunnion and severe osteolysis behind the cup may be consistent with findings associated with metal debris and trunnionosis.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the metal debris and osteolysis cannot be confirmed, and it cannot be concluded that the reported 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.

Manufacturer Narrative

It was reported that a second hip revision surgery was performed.During the revision, the bhr cup, hemi head and sleeve were removed.The 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 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 and hemi head.Similar complaints have been identified for the sleeve and this 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.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 a result of the reported event.The available medical documents were reviewed.Although it was reported that the patient was treated for infection, no supporting labs were provided and it was reported that the preoperative workup for infection was negative.The reported pain, elevated metal ions along with intraoperative findings of black corrosion noted on the trunnion and severe osteolysis behind the cup may be consistent with findings associated with metal debris and trunnionosis.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the metal debris and trunnionosis cannot be confirmed, and it cannot be concluded that the reported 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: 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: 9659358
• MDR Text Key: 177377513
• Report Number: 3005975929-2020-00029
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2011
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 65940
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356108 ANTHOLOGY HO POROUS SZ 8 06HM04658.; 74122546 HEMI HEAD 46MM 10722.; 74122546 HEMI HEAD, LOT 10722.; 74222200 MODULAR SLEEVE PLUS 0MM 12/14 11443.; 74222200 MODULAR SLEEVE, LOT 11443.; ANTHOLOGY STEM 71356108/ 06HM04658.; HEMI HEAD 74122546/ 10722.; MODULAR SLEEVE 74222200/ 11443.; ANTHOLOGY STEM 71356108/ 06HM04658; HEMI HEAD 74122546/ 10722; MODULAR SLEEVE 74222200/ 11443
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR