MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-048

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that: "i've operated a (b)(6) physiotherapist (healthy and thin) about 15 months ago.I've used a anterolateral approach.During the operation there was a small crack that i fixed with a cable without any practical effect.I used j&j pinnacle gription and corail stem with ceramic head and altrx liner.She healed very well and had normal and active life without any complaints.Two days ago, while sitting she felt a sudden pain at here left buttock (without any trauma) and as she started to try walking-she heard squawking.I saw her today and heard the noise myself and found some limited rom in the hip.On xray i think that the poly is broken and the head is fine.I will have to revise here soon.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the x-rays provided of the pinn sector w/gription 48mm could confirm a disassociation event.It is reasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent to the liner disassociation and does not signify any product error.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).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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the x-rays provided of the pinn sector w/gription 48mm could confirm a disassociation event.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the x-rays provided of the pinn sector w/gription 48mm (cup) could confirm a disassociation event.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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc's against the provided product code/lot code combination, it is reasonable to conclude that there are no previously identified anomalies with regards to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: PINN SECTOR W/GRIPTION 48MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13391833
• MDR Text Key: 284679645
• Report Number: 1818910-2022-01892
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010289
• UDI-Public: 10603295010289
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-32-048
• Device Catalogue Number: 121732048
• Device Lot Number: 9457723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX48OD; CORAIL AMT COLLAR SIZE 11; DELTA CER HEAD 12/14 32MM +1