MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722052

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

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

Event Date 09/01/2020

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

A patient was treated with a hip tep implantation in 2017 and now complained about sudden restriction of range of movement and a squeaking sound in the left hip joint.Intra op x-ray shows an eccentric placement of the hip head and a subluxated inlay with expected pre-damage.X-ray post op inconspicuous.

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.Patient code: removed code for absence of treatment and replaced with no code available (3191) to capture surical 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.Based on the other received devices, the reported allegation could be confirmed.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 : dhr reviewed and no deviations or anomalies were found.

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: a2 (age), a4, b5, b7 and d6b.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.

Event Description

Aspiration of left hip occurred on (b)(6) 20 ¿ negative for infection.Revision operative notes (b)(6) 2020, indicate the patient received a left total hip revision due to inability to ambulate, inlay damage and subluxation from the cup (disassociation).Upon entering the joint, it is indicated that there were 2 chips that came off of the inlay, these were removed from the joint.The head and liner were exchanged.The surgery was completed.These revision notes go on to indicate that after a review of the prosthetic stickers when preparing the surgery report on the following morning revealed that the wrong inlay (duraloc) had been inserted into the cup (pinnacle).The patient was informed and a revision was planned.

• Brand Name: PINNACLE SECTOR II 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: 10606986
• MDR Text Key: 209185569
• Report Number: 1818910-2020-21230
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121722052
• Device Lot Number: 8560181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 NON COL HO SIZE 10.; HIP BALL BIOLOX 32 +9 12/14.; PINN MAR +4 10D 32IDX52OD.; UNKNOWN HIP FEMORAL HEAD.; PINN MAR +4 10D 32IDX52OD; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 72