MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BASE D26 H25 COLLARLESS; REEF IMPLANTS : HIP ACETABULAR AUGMENT

Catalog Number L92406

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: ceramic ball head, cone size 12/14, 28m (competitor) shell, cemented, stainless steel sz 49 (competitor).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient was implanted with a trochanteric component (l92408) plus locking screw in her left hip.Her hip movement is extremely limited due to impingement of the trochanter against the pelvis and the leg is 1.4cm too short now.The patient's husband was asking if the models l92406 and l92408 interchangeable onto her femor stem ( metaphyso diaphyseal, 014lg.225)? would the different size locking screws be a problem? doi: unknown - dor: none reported (left hip).

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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: h6 (patient codes) corrected: h6 (device code) h6 patient code: no code available (3191) used to capture the absence of treatment, joint instability and limb asymmetry.Correct device code was migration and not unintended movement.

• Brand Name: BASE D26 H25 COLLARLESS
• Type of Device: REEF IMPLANTS : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10144589
• MDR Text Key: 194949287
• Report Number: 1818910-2020-13657
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: L92406
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BASE D26 H25 COLLARLESS; FEMOR STEM, METAPHYSO DIAPHYSEAL, O 14LG.225; KNOCHENZEMENTEN, PAIACOS R+G 2X40 (COMPETITOR); REINFORCEMENT RING WITH HOOK 60 (COMPETITOR)