MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 57/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018960
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha surgery had been performed, the patient experienced a mechanical dislocation of the ceramic ball head delta 28 l and polarcup xlpe insert 57/28 non-cem.A revision surgery was performed to replace such devices.The patient outcome is unknown.
Additional Manufacturer Narrative
Results of investigation: the devices used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the x-rays provided confirms the report but also notes radiolucency under the medial and anteriorly tibial base plate.Without the requested device, the length of time in-situ, activity level, the requested clinical information, lab reports or the implantation/revision reports the root cause of the reported laxity nor can the reported infection be confirmed.However, we cannot rule out micro-motion as a contributing factor.The impact to the patient beyond the revision cannot be determined.Since the patient is stable with a brace, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: POLARCUP XLPE INSERT 57/28 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10491258
• Report Number: 9613369-2020-00164
• Device Sequence Number: 14125135
• Product Code: LPH
• UDI-Device Identifier: 07611996111507
• UDI-Public: 07611996111507
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 75018960
• Device Catalogue Number: 75018960
• Device Lot Number: B1924648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention