MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-156
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
On monday, (b)(6) at (b)(6) hospital, dr (b)(6) performed a left hip revision arthroplasty on a patient due to stem subsidence and then instability of the hip.Patient¿s primary hip was performed on (b)(6) 2020 at (b)(6) hospital by dr.(b)(6).Patient experienced a fall that required revision surgery at (b)(6) on (b)(6) 2021 by dr (b)(6) who elected to remove the primary stem and replace it with the competitor¿s stem.He retained the primary pinnacle sector 2 shell but used a different poly (ref: (b)(4)).Since the (b)(6) revision the patient has experience instability and dislocations (dr.(b)(6) cannot recall how many dislocations).On monday, (b)(6) at (b)(6) dr.(b)(6) exposed the joint space, removed the loose stryker rms femoral head and stem.Upon inspection of the pinnacle acetabular shell sz 56 and the altrx 56/40 +4 10 deg liner, dr (b)(6) elected to remove them as well in case of infection.Dr.(b)(6) used the pinnacle liner removal tool to remove the liner and then removed the well grow in pinnacle shell with a trial liner and zimmer cup out system.Dr.(b)(6) is electing to replace all implants with a total zimmer construct.No instrumentation broke during surgery.There were no time delays associated with depuy.There was no mention that the products did not perform as expected.Doi: (b)(6) 2020, dor: (b)(6) 2021, left hip.
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: ALTRX +4 10D 40IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12377336
• Report Number: 1818910-2021-18820
• Device Sequence Number: 3924275
• Product Code: LPH
• UDI-Device Identifier: 10603295016564
• UDI-Public: 10603295016564
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1221-40-156
• Device Catalogue Number: 122140156
• Device Lot Number: J6791F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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: ALTRX +4 10D 40IDX56OD; COMPETITOR HEAD (STRYKER); COMPETITOR STEM (STRYKER); PINNACLE SECTOR II CUP 56MM; ALTRX +4 10D 40IDX56OD; COMPETITOR HEAD (STRYKER); COMPETITOR STEM (STRYKER); PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention