MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	626-00-38D
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Just after opening the mdm cobalt chrome liner, the surgeon noticed that some paper (similar to a sticker or label) was attached to the inner side of the liner itself.He was able to clean the liner using some alcohol and then implant it.
Additional Manufacturer Narrative
An event regarding foreign matter involving an mdm liner was reported.The event was confirmed.Conclusions: a memo provided by the manufacturing cell concluded that the visual inspection requirements make it unlikely that this isse originated in the manufacturing process, but subsequently adhered to the mdm cup as part of the handling of the complaint device.The replication analysis also indicates that it is extremely unlikely that this non-conformance occured at the manufacturing site.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Just after opening the mdm cobalt chrome liner, the surgeon noticed that some paper (similar to a sticker or label) was attached to the inner side of the liner itself.He was able to clean the liner using some alcohol and then implant it.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7302812
• Report Number: 0002249697-2018-00570
• Device Sequence Number: 11337775
• Product Code: LZO
• UDI-Device Identifier: 04546540666000
• UDI-Public: 04546540666000
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 626-00-38D
• Device Lot Number: 60056503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR