MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732056

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/24/2020

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

It was reported that during reaming of the acetabulum, a small section of metal from the dome of the acetabular reamer broke off and was lodged in the patient¿s bone.This broken piece of metal was not immediately noticed and the procedure continued.Once all final implants were placed and final xrays were preformed, the metal piece was now visible on x-ray.The surgeon chose not to attempt to retrieve the metal piece because he felt that removing the acetabular cup would cause harm to the patient.Subsequently, the patient experienced instability and dislocation of the operative hip in pacu.The surgeon decided to take the patient back to the operating room the same day to address the patient¿s instability by revising the acetabular component.Once the acetabular cup was explanted, the surgeon was able to explant the piece of broken metal as well.A new acetabular cup was implanted and a stability test was performed.The surgeon was satisfied with the stability of the hip.No surgical delay.

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#, expiration and udi), d11, g5 and h4.Corrected: d1, d2, d2b, d4 (catalog).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 x-rays provided on (b)(4) could not confirm the reported allegation.The root cause could not be determined.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.H10 additional narrative: added: a2 (dob), h5 corrected: a1, b1, b2, h4.

Event Description

The surgeon removed the cup due to suboptimal position causing dislocation.The metal piece was removed while changing cup position.Affected side: left.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ corrected: h6 (device).

• Brand Name: PINN SECTOR W/GRIPTION 56MM
• 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: 10246674
• MDR Text Key: 200773833
• Report Number: 1818910-2020-15301
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121732056
• Device Lot Number: 9492955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC-2; ALTRX NEUT 40IDX58OD; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR