MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. EP-FIT PLUS PLASTIC INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number UNKN1101004

Device Problems Off-Label Use (1494); Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 07/01/2018

Event Type  Injury  

Event Description

On the literature article named "severe wear and multiple pseudotumor formation due to revision for ceramic head breakage after ceramic-on-ceramic total hip arthroplasty: a case report", the authors of the study reported that, 8 months after the first revision surgery when a mop system was implanted in the patient´s right hip (covered under (b)(4)), the patient was admitted again to the hospital with low fever, loss of appetite and weight loss.X-ray showed huge soft tissue mass around right hip prosthesis and computed tomographic (ct) scan showed a mass extending to the pelvis without bone destruction.Serum ion concentrations (cobalt, chromium and titanium) were significantly elevated.A revision surgery was performed and extensive metallosis and dark gray tissue was visible around the joint.The acetabular shell and femoral stem were well fixed, and therefore, these components were retained.A severe wear was noted around the metal head and polyethylene liner, which were exchanged.The taper exhibited wear without fracture, therefore a titanium sleeve (zimmer) was implanted.Synovectomy and extensive debridement were conducted before closing the wound.The outcome of the patient remains unknown.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H3, h6: the study of xing et.Al.[1] reports one case of severe wear and multiple pseudotumor formation due to revision for ceramic head breakage.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported, that the patient suffered from a pseudo tumor following the implantation of a metal ball head after a ceramic component fracture.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.According to ifu lit.No.12.23 ed.03/21 a metal ball head should not be implanted after a fracture of a ceramic component.The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.Review of past corrective actions was performed.No further escalation is required.Based on our investigations the failure mode and the relationship between the device and the reported event can be confirmed reviewing the case study.The root cause is attributed to an off-label use.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.[1]: xing, d., yang, c., li, r.Et al.Severe wear and multiple pseudotumor formation due to revision for ceramic head breakage after ceramic-on-ceramic total hip arthroplasty: a case report.Bmc musculoskelet disord 20, 332 (2019).Https://doi.Org/10.1186/s12891-019-2722-x.

• Brand Name: UNKN. EP-FIT PLUS PLASTIC INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12823596
• MDR Text Key: 282562746
• Report Number: 9613369-2021-00407
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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 Catalogue Number: UNKN1101004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male