MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-152
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was completed due to unspecified issue with materials.Doi: (b)(6) 2015.Dor: unknown.Affected side unknown.
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.
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
Revision surgery was completed due to unspecified issue with materials.Doi: (b)(6) 2015.Dor: unknown.Affected side unknown.
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.
Event or Problem Description
Additional information was received stated the following: a.What is the affected side involved in this event? left or right? left side.B.Was there a surgical delay? if yes, what is the duration of the delay? the delay during the revision was significant, the whole surgery took about three hours, removal of the previous insert and cleaning the joint lasted about two hours.C.Was there any suggestion by anyone indicating that there was or may be an alleged deficiency with the reported products? after the revision the operator suggested that the previous insert could be defective and that was reason for the revision.1.It was indicated that "insert could be defective", please specify what was the deficiency of the liner/insert? as the time between the primary surgery and the revision surgery was relatively short and the insert was significantly worn in one of its part the operator suggested that the reason was a defective material of the insert.He said that during his long experience he was never forced to change the insert for a new one after such short time and this exact situation is far from normal.D.Was/were there any adverse consequence/s to the patient that led to the revision surgery? patient reported significant pain, worsening of the movement range and even the occurrence of noticeable noises from the joint.
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.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: 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 report was received for examination.Visual examination of the returned liner confirmed a remarkable worn condition.Also, there was found evidence signs that poly liner and cup underwent a disassociation event.Although that it is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup, it cannot be confirmed that liner was causing an interacting sound post disassociation event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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.

• Brand Name: PINN MAR +4 10D 36IDX52OD
• 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 drive; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13539152
• Report Number: 1818910-2022-02886
• Device Sequence Number: 17192167
• Product Code: LPH
• UDI-Device Identifier: 10603295014577
• UDI-Public: 10603295014577
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/15/2022

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 Expiration Date: 02/01/2020
• Device Model Number: 1219-36-152
• Device Catalogue Number: 121936152
• Device Lot Number: 638919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 04/04/2022; 05/09/2022; 05/14/2022; 07/01/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/18/2022; 04/05/2022; 05/10/2022; 05/19/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2015
• 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: DELTA CER HEAD 12/14 36MM +1.5; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown