MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN DP REVSN W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121717054

Device Problems Material Disintegration (1177); Noise, Audible (3273); Separation Problem (4043)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.(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 the patient presented to the surgeon with pain and clicking in her hip.On x-ray, it appeared that the poly had worn thru.Knowing it had only been in 1.5 years, this was likely not the case.The patient had no recollection of a traumatic event, nevertheless the surgeon suspected that the liner spun out at one point.Upon examination in the or, the metal head had indeed been articulating on the metal shell and worn down the metal on the rim of the shell.The cup was removed because the locking taper in the shell had been compromised.The 54 deep profile cup was replaced with a 56 multi-grip with a 40 liner and metal +5 head.

• Brand Name: PINN DP REVSN W/GRIPTION 54MM
• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 8181944
• MDR Text Key: 130973927
• Report Number: 1818910-2018-78776
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009450
• UDI-Public: 10603295009450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121717054
• Device Lot Number: C62739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR