MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-058
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient is due to be revised this week beginning (b)(6) 2020 corail/pinnacle thr (left side) in (b)(6) 2012 3-4 weeks ago (mid (b)(6) 2020) ¿ stopped to pick something up from floor ¿ sudden groin pain ¿ which settled quickly no ongoing pain since then.Only squeaks when walking and using stairs.Audible (classic) squeak when walking.Patient shown his post op and previous films as compared to today ¿ liner dissociation noted and explained given a pair of crutches.
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.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).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:  added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: visual examination of the returned device and x-ray image finds evidence to support disassociation of the liner from the cup while implanted.Error in material or manufacture was not identified.The information received will be retained for potential series investigations if triggered by trend analysis 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: 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE 100 ACET CUP 58MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10942499
• Report Number: 1818910-2020-26104
• Device Sequence Number: 3007318
• Product Code: LPH
• UDI-Device Identifier: 10603295008583
• UDI-Public: 10603295008583
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-01-058
• Device Catalogue Number: 121701058
• Device Lot Number: 205868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 01/26/2021; 02/11/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/18/2020; 02/02/2021; 02/12/2021
• 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: APEX HOLE ELIM POSITIVE STOP.; ARTICUL/EZE BALL 32 +5 BR.; CORAIL AMT COLLAR SIZE 14.; PINN MAR NEUT 32IDX58OD.; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; CORAIL AMT COLLAR SIZE 14; PINN MAR NEUT 32IDX58OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 79