MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article abstract entitled, ¿validation of use of transverse acetabular ligament and mechanical angle guide device to orient the acetabular cup¿ by archit agarwal, et al; published by journal of clinical orthopaedics and trauma (2020), vol.11, pp.S766-s771, was reviewed.The purpose of this study was to verify the reliability of using the transverse acetabular ligament as an anatomical landmark to orient the cup in primary tha and to compare that to cups placed with a mechanical angle guide device in 35 patients in a three-year time period beginning in september 2016.The patient received a corail stem and pinnacle cup.A variety of femoral heads and acetabular liners were used.The manufacturers were not specified but are assumed to be depuy products.Results: 1 reported joint dislocation.Treatment was not specified.15 cups in 45-50 degrees anteversion identified in radiographic studies.No treatment provided and no patient consequences reported.Radiographic images are available on pages s767 and s768.Captured in this complaint: 1 unk liner and 1 unk head: pec: implant dislocation.15 unk cups: pec: implant malposition.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> no device associated with this report was received for examination.Review of the attached images could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot
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> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10879849
• MDR Text Key: 239589562
• Report Number: 1818910-2020-25182
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1