MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR ETO NEUT 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122432052

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

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

The primary surgery was performed on (b)(6) 2020 via tha.The implants were used normal.Post-operative x-ray was well, however, on (b)(6) 2020 anterior dislocation occurred.The surgeon plans the revision surgery on (b)(6) 2020 by replacing the liner and the head as the first choice, if the dislocation still occur, the surgeon plans to remove the stem and perform derotation with s-rom stem.The surgeon commented that it was not a product factor.The primary surgery via tha was performed after a procedure via rao, the shape of pelvic was different from normal.So, there was possibility that the impingement occurred posterior.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a1, a2, d4 (lot # and udi), d7, g5, h4 and h6 (patient).Corrected: d1, d2, d2b, d4 (catalog), d11 and h1.H6 patient code: no code available (3191) used to capture the device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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 : 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: PINN MAR ETO NEUT 32IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10754556
• MDR Text Key: 215291141
• Report Number: 1818910-2020-23513
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K102423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122432052
• Device Lot Number: J4457N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTIS COLLARED HIGH SIZE 5; ACTIS COLLARED STD SIZE 6; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +1; PINN SECTOR W/GRIPTION 52MM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention