MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTLESS (TI/HA); PROSTHESIS, HIP, SEMI-CONSTRAIN, METAL/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMEN

Catalog Number UNKN1102402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that, according to data obtained from the endoprothesenregister - deutschland (eprd), a total of three hundred and forty nine (349) patients underwent a primary implantation of a thr system that included a polarstem valgus femoral prosthesis with a bearing combination of several components between (b)(6) 2015 and (b)(6) 2021.From this cohort, one (1) patient required a revision surgery due to a postoperative diagnosis of malposition/malalignment.The postoperative period during which this intervention was necessary, as well as the identity of the devices explanted and the prosthesis implanted in exchange remains unknown.The eprd provided this information as part of a cumulative statistical study regarding failure frequency, therefore there is no additional information available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: according to data obtained from the endoprothesenregister - deutschland (eprd) [1], a total of three hundred and forty nine (349) patients underwent a primary implantation of a thr system that included a polarstem valgus femoral prosthesis with a bearing combination of several components between (b)(6) 2015 and (b)(6) 2021.From this cohort, one (1) patient required a revision surgery due to a postoperative diagnosis of malposition/malalignment.The complaint device, used in treatment, was not received for investigation and a visual inspection could not be performed.The exact part and batch number of the device is not known.Therefore, the batch record review could not be performed and it is not possible to investigate whether the reported devices met manufacturing specifications upon release for distribution.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Furthermore, the ifu ((b)(4)) lists several possible adverse effects resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.A review of past corrective actions was performed.No further escalation is required.For the medical investigation, no relevant supporting clinical information could be provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided, this complaint will be re-evaluated.Based on the performed investigations, a relationship between the reported devices and the reported incidents cannot be excluded but the root cause of the problem stays undetermined due to insufficient information.A relationship between the reported event and the device cannot be confirmed.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.

• Brand Name: UNKN. POLARSTEM CEMENTLESS (TI/HA)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAIN, METAL/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMEN
• 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: 15279231
• MDR Text Key: 298458088
• Report Number: 9613369-2022-00479
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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: UNKN1102402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 09/10/2022
• Supplement Dates FDA Received: 09/12/2022
• 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: UNKN FEM HEAD AARAU CERAMIC
• Patient Outcome(s): Other