MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121711052

Device Problem Naturally Worn (2988)

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

Event Date 10/10/2020

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

Revision total hip replacement; hospital (b)(6) 2020: revision due to dislocation and instability.Case will likely have previous reports as previous revision (b)(4) has occurred for instability neck of srom stem notched due to impingement with acetabular component.Evidence of macroscopic staining from metal wear impingement of femoral stem with acetabular component.

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: d4 (lot #, udi), d6, g5, h4; corrected: d1, d2, d2b, d4 (catalog), d11 and h6 (patient).Patient code: removed code for joint instability and device revision or replacement and replaced with no code available (3191) to capture surgical intervention.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE 100 HA ACET CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10727099
• MDR Text Key: 212767213
• Report Number: 1818910-2020-23225
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K031495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121711052
• Device Lot Number: XL9EN1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/25/2020; 12/15/2020
• Supplement Dates FDA Received: 11/05/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN LNR CON +4 NEUT 28IDX50OD.; S-ROM*HEAD FEMORAL COCR 28+0.; S-ROM*SLEEVE PRX ZT HA 14B-SML.; S-ROM*STM STD,36NK,14X09X130.; UNK HIP FEMORAL SLEEVE.; UNKNOWN HIP FEMORAL STEM.; UNK HIP FEMORAL SLEEVE; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR