MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-050
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Distress (2329); Ambulation or Postural Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised to address pain.The stem was also fractured and had to be removed well ingrown sleeve and distal aspect of the fractured stem.Doi: unknown; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer 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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos revealed that complaint condition cannot be confirmed since the device is not clearly shown in the evidence provided.No evidence of wear or deterioration of polyethylene material was observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Medical records received.Physical therapy lower extremity functional scale survey results in (b)(6) 2016 indicate a marked disability in running, lifting heavy items, or performing heavy activities around the home.The patient walks with the assistance of a cane.The patient indicated in the survey she has a medical history of obesity, hypertension, arthritis, and osteoporosis, and has a pacemaker implanted, as well as bilateral total hip replacements.It was reported that the primary right hip had been implanted in 2006, and the left hip had been implanted in (b)(6) 2016.This information precedes the current right hip adverse event and revision.

• Brand Name: PINN MAR NEUT 28IDX50OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16787922
• Report Number: 1818910-2023-08456
• Device Sequence Number: 14872704
• Product Code: LPH
• UDI-Device Identifier: 10603295013297
• UDI-Public: 10603295013297
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 1219-28-050
• Device Catalogue Number: 121928050
• Device Lot Number: ZW7ER1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/05/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/09/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUTRAL HEAD 20-MM COBALT-CHROME; PINN MAR NEUT 28IDX50OD; PINNACLE SECTOR II CUP 50MM; PINNACLE SECTOR II CUP 50MM; PROXIMAL SLEEVE 14B LARGE; S-ROM 14 X 9 X 130 +4 LATERAL OFFSET; S-ROM*HEAD FEMORAL COCR 28+0; S-ROM*SLEEVE PRX ZTT, 14B-LRG; SROM*STM ST,30+4L NK,14X09X130
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Race: White