MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN BANTAM W/GRIPTION 44MM; HIP ACETABULAR CUP

Catalog Number 121730044

Device Problems Disassembly (1168); Material Disintegration (1177); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); No Information (3190)

Event Date 04/29/2015

Event Type  Injury  

Event Description

Patient was revised to address squeaking in the hip.It was also noted that the liner was found to be disassociated.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

**update received 9/23/15.The sales rep has reported the revision of the acetabular cup due to a recurring disassociation.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Examination of the returned femoral head and acetabular liner confirm disassociation in vivo.A search of the complaints databases identified no other reports against the acetabular liner or cup product/lot code combinations.Review of the liner device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.The root cause is undetermined and the investigation has found no product contribution to the reported event.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Litigation records received.Litigation alleges pain and squeaking in the hip.Radiograph images revealed that the prosthetic head in the cup showed findings consistent with significant polyethylene wear or failure.

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.H10 additional narrative: added: b5, b7 and d10 corrected: a2 (age), g1 and h6 (patient).Replaced surgical intervention with device revision or replacement.

Event Description

After review of medical records, patient was revised to addressed failure right total hip arthroplasty.A standard posterior approach to the hip was made.The piriformis short external rotator tendons could not be identified in the posterior scar.There was extensive omentalis of the greater trochanteric bursa.All blackened tissue was excised.The polyethylene was loose in the cup.There is a piece of polyethylene in the anterior portion of the joint which was removed.

• Brand Name: PINN BANTAM W/GRIPTION 44MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4748725
• MDR Text Key: 5821641
• Report Number: 1818910-2015-20054
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/08/2017
• Device Catalogue Number: 121730044
• Device Lot Number: BX1F21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 05/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 04/19/2018; 09/05/2018; 07/20/2021
• Supplement Dates FDA Received: 05/27/2015; 10/28/2015; 12/17/2015; 12/17/2015; 04/25/2018; 09/21/2018; 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 28MM +1.5; PINN BANTAM W/GRIPTION 44MM; PINN MAR +4 10D 28IDX44OD
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 78