MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, according to data obtained from the endoprothesenregister - deutschland (eprd), from a total two hundred twenty five (225) patients who underwent primary implantation between october-2013 and march-2021 with a thr system that included a cementless non-ha coated polarcup and a polarcup liner, four (4) patients required a revision surgery due to a postoperative unspecified infection.The identity of the devices explanted during this procedure 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.

Manufacturer Narrative

According to data obtained from the endoprothesenregister - deutschland (eprd) [1], it was reported that, from a total two hundred twenty five (225) patients who underwent primary implantation between october-2013 and march-2021 with a thr system that included a cementless non-ha coated polarcup and a polarcup liner, four (4) patients required a revision surgery due to a postoperative unspecified infection.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 (lit.No.12.23 ed 03/21) 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.[1]: german arthroplasty registry (eprd).Smith & nephew gmbh - polarcup cementless (h1.1 acetabular component).2021-12-15, germany internal complaint reference number: (b)(4).

• Brand Name: UNKN. POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA)
• 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: 14995158
• MDR Text Key: 295768982
• Report Number: 9613369-2022-00338
• Device Sequence Number: 1
• Product Code: LWJ
• 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,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 08/16/2022
• Supplement Dates FDA Received: 08/26/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: UNKN FEMORAL HEAD IMPL; UNKN. POLARCUP PLASTIC INSERT; UNKN. POLARSTEM CEMENTLESS (TI/HA)
• Patient Outcome(s): Other; Hospitalization