MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X 46MM; PROSTHSIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTD

Model Number	71334946
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr the r3 xlpe poly liner did not lock r3 acetabular cup and while surgeon was trying to remove the acetabular cup and the screws, the acetabulum got damaged.Due to which we could not operate further.
Additional Manufacturer Narrative
Additional information: the device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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.

• Brand Name: R3 20 DEG XLPE ACET LNR 28MM X 46MM
• Common Device Name: PROSTHSIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720204
• Report Number: 1020279-2020-00599
• Device Sequence Number: 2352796
• Product Code: JDI
• UDI-Device Identifier: 03596010598097
• UDI-Public: 03596010598097
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71334946
• Device Catalogue Number: 71334946
• Device Lot Number: 17HM07197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1