MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121730062

Device Problem Loss of Osseointegration (2408)

Patient Problems Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Weakness (2145); Hypoesthesia (2352); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Claim and medical records received.After review of claim and medical records, it was stated that the patient was revised to address pain and aseptic loosening of cup component.Stiffness, limping, clicking, popping, weakness and numbness were also noted.Operative notes reported slightly brown tented and translucent fluid, the tissue is stained dark gray consistent of metallosis, two superior cysts were curetted and there was no acetabular bony ingrowth noted.When removing the acetabular shell, three screws broke but only one was fully extracted and the two screws were recessed since they were embedded into the sclerotic bone.Mri reported trochanteric bursitis.X-ray reported aseptic loosening of acetabular component and has metal wear debris reaction.Doi: (b)(6) 2010; dor: (b)(6) 2018; left hip.

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 related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MULTIHOLE W/GRIPTION 62MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8544302
• MDR Text Key: 142901592
• Report Number: 1818910-2019-91465
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010036
• UDI-Public: 10603295010036
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 121730062
• Device Lot Number: BX4C11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2007
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 98