MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 32IDX54OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-32-754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the patient that "in (b)(6) 2019 i had hip revision surgery, which included the use of the depuy constrained acetabular liner.Initially i did not notice any difference from my previous liner.However, as the months have passed, i have experienced a clicking feeling/movement in my hip when i move in certain ways.For instance, walking up stairs, i feel a clicking (for lack of a better description) when i lift on the leg with the revision.Also, when i bend in certain ways, get up from a sitting position at times, and other activities.Since i have experienced dislocation in the past, i find this very disconcerting.My previous dislocations had no advance ¿clicking¿, just the dislocation.My doctor has not provided me with much information on limitations of my activities.In fact, the last time i brought it up he said ¿just be happy you can walk¿.Unfortunately, i did not pursue the conversation at the time.I¿m sure he doesn¿t know what i am experiencing, since it seems this is not the common constrainer experience.My question for you is, can you provide me with information on what one should expect after the constrainer has been inserted? does it mean that dislocation is eminent because of the movement i am feeling? what are there precautions i should be taking? is this clicking/movement normal in cases such as mine? my surgeon is an excellent doctor and has helped me through very difficult circumstances, i just don¿t believe he has the answers i need in this instance.Any insight and/or help you can provide is appreciated." doi: (b)(6) 2009.Dor: (b)(6) 2019.Right hip.Please see (b)(4) for 1st revision.
Additional 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.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: PINN LNR CON +4 10D 32IDX54OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10991713
• Report Number: 1818910-2020-26793
• Device Sequence Number: 779309
• Product Code: KWZ
• UDI-Device Identifier: 10603295012009
• UDI-Public: 10603295012009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1218-32-754
• Device Catalogue Number: 121832754
• Device Lot Number: B4TB11000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET HEAD; BIOMET HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR