MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR ETO LIP LNR 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122432256

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 04/04/2020

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 on (b)(6) 2017, the primary surgery was performed via tha with the head (p/n: 136532110), the stem (p/n: 900554210), the sleeve (p/n: 550503) and the liner (p/n: 122432256) in question.On (b)(6) 2020 the patient underwent the revision surgery due to unknown reason.In the revision surgery, after the surgeon removed the head, the stem and the sleeve, he found that the liner worn out, and he replaced the liner.The surgery was completed successfully without any surgical delay.No further information is available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Brand Name: PINN MAR ETO LIP LNR 32IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9943574
• MDR Text Key: 187073573
• Report Number: 1818910-2020-10561
• Device Sequence Number: 1
• Product Code: JDJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122432256
• Device Lot Number: 640619
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 9/10 32MM -3; PINN MAR ETO LIP LNR 32IDX56OD; S-ROM*SLEEVE PRX ZTT, 14D-SML; SROM 9/10 14X9X175 36 N; DELTA CER HEAD 9/10 32MM -3; PINN MAR ETO LIP LNR 32IDX56OD; S-ROM*SLEEVE PRX ZTT, 14D-SML; SROM 9/10 14X9X175 36 N
• Patient Outcome(s): Required Intervention