MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-052
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pinnacle metal on metal revised to ceramic or poly.Revised due to elevated cobalt ions levels (17) and metallosis.No evidence of pseudotumor.Corrosion on the trunnion.Doi: (b)(6) 2003.Dor: (b)(6).Affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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: 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 : the device associated with this complaint was not returned.However, photos were provided for review.Review if the provided photos found insufficient evidence that would suggest implant corrosion.The reported condition was not confirmed.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.Per wi-3430, it has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.
Event or Problem Description
Sticky note and pinnacle mom litigation records received.Sticky note has no new information provided.Litigation alleges metallosis, elevated metal ions, adverse local tissue reaction, pseudotumor, pain, stiffness, cardiomyopathy, loss of motion in both hips, suffering and emotional distress.Doi: (b)(6) 2003; dor:(b)(6) 2022 ; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not returned.However, photos were provided for review.Review if the provided photos found insufficient evidence that would suggest implant corrosion.The reported condition was not confirmed.The reported condition was not confirmed.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.

• Brand Name: PINNACLE 300 ACET CUP 52MM
• Common Device Name: 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16146235
• Report Number: 1818910-2023-01061
• Device Sequence Number: 5655298
• Product Code: LPH
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/12/2023

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: 1217-03-052
• Device Catalogue Number: 121703052
• Device Lot Number: WW2DR1013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/06/2023; 06/02/2023; 06/12/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/17/2023; 02/06/2023; 06/12/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2002
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; TRI-LOCK TI 10.0 LAT OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 48 KG